Methods, Systems and Devices for Surgical Access and Insertion

ABSTRACT

The various embodiments herein relate to systems, devices, and/or methods relating to surgical procedures, and more specifically for accessing an insufflated cavity of a patient and/or positioning surgical systems or devices into the cavity.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application claims priority as a continuation of U.S. applicationSer. No. 13/738,706, filed Jan. 10, 2013 and entitled “Methods, Systems,and Devices for Surgical Access and Insertion;” which claims priority toProvisional Application No. 61/584,947, filed Jan. 10, 2012; andProvisional Application No. 61/683,483, filed Aug. 15, 2012; all ofwhich are hereby incorporated herein by reference in their entireties.

FIELD OF THE INVENTION

The various embodiments herein relate to systems, devices, and/ormethods relating to surgical procedures, and more specifically foraccessing an insufflated cavity of a patient and/or positioning surgicalsystems or devices into the cavity.

BACKGROUND OF THE INVENTION

Invasive surgical procedures are essential for addressing variousmedical conditions. When possible, minimally invasive procedures such aslaparoscopy are preferred.

However, known minimally invasive technologies such as laparoscopy arelimited in scope and complexity due in part to 1) mobility restrictionsresulting from using rigid tools inserted through access ports, and 2)limited visual feedback. Further, the technologies are also limited dueto difficulties relating to maintaining access to the surgical cavitywhile also maintaining insufflations of the cavity.

There is a need in the art for improved surgical methods, systems, anddevices.

BRIEF SUMMARY OF THE INVENTION

Discussed herein are various surgical access and insertion devices andmethods.

In Example 1, a surgical insertion device comprises a canister defininga lumen, a top cap coupled to a proximal end of the canister, and anincision port removably coupled to a distal end of the canister. Thecanister is sized to receive a surgical device in the lumen. The top capcomprises at least one lumen defined in the top cap, wherein the atleast one lumen is configured to receive a support rod. The incisionport comprises a fluidic sealing component configured to maintain afluidic seal.

Example 2 relates to the surgical insertion device according to Example1, wherein the lumen is fluidically sealed in relation to ambient air.

Example 3 relates to the surgical insertion device according to Example1, wherein the canister comprises a flexible material or a substantiallyrigid material.

Example 4 relates to the surgical insertion device according to Example1, wherein the canister comprises a flexible portion and a substantiallyrigid portion.

Example 5 relates to the surgical insertion device according to Example1, wherein the canister has a cylindrical shape, a spherical shape, or aconical shape.

Example 6 relates to the surgical insertion device according to Example1, wherein the canister comprises at least one rib structure.

Example 7 relates to the surgical insertion device according to Example1, wherein the fluidic sealing component comprises a sealable sleevedevice, a flexible seal component, a removable lid seal component, or aflap seal component.

Example 8 relates to the surgical insertion device according to Example1, wherein the top cap comprises at least one of a pressure reliefvalve, at least one threaded lumen, a detachable cable harness, and aclamp projection.

Example 9 relates to the surgical insertion device according to Example1, further comprising an outer handle set coupleable to the top cap.

Example 10 relates to the surgical insertion device according to Example1, further comprising at least one measurement mechanism coupled to thetop cap or the incision port.

Example 11 relates to the surgical insertion device according to Example1, wherein the canister comprises at least one access port, wherein theat least one access port is a hand access port or a side access port.

In Example 12, a surgical insertion device comprises a flexible canisterdefining a lumen, a top cap coupled to a proximal end of the canister,an incision port removably coupled to a distal end of the canister, anda first measurement mechanism coupled with the top cap or the incisionport. The canister is sized to receive a surgical device in the lumen.The top cap comprises at least one lumen defined in the top cap, whereinthe at least lumen is configured to receive a support rod. The incisionport comprising a fluidic sealing component is configured to maintain afluidic seal. The first measurement mechanism is configured to measurethe insertion depth of the surgical device.

Example 13 relates to the surgical insertion device according to Example12, wherein the first measurement mechanism comprises a sensor, a stringmeasurement system, a substantially rigid structure system, or a camera.

Example 14 relates to the surgical insertion device according to Example12, wherein the fluidic sealing component comprises a sealable sleevedevice, a flexible seal component, a removable lid seal component, or aflap seal component.

Example 15 relates to the surgical insertion device according to Example12, wherein wherein the top cap comprises at least one of a pressurerelief valve, at least one threaded lumen, a detachable cable harness,and a clamp projection.

Example 16 relates to the surgical insertion device according to Example12, further comprising a second measurement mechanism coupled to the topcap or the incision port, the second measurement mechanism configured tomeasure any tilt of the flexible canister.

In Example 17, a surgical insertion device comprises a canister defininga lumen, a top cap coupled to a proximal end of the canister, and anincision port removably coupled to a distal end of the canister. Thecanister is sized to receive a surgical device in the lumen, wherein thesurgical device is a robotic surgical device comprising two arms. Thetop cap comprises a pressure relief valve and at least one lumen definedin the top cap, wherein the at least one lumen is configured to receivea support rod. The incision port comprises a fluidic sealing componentconfigured to maintain a fluidic seal.

Example 18 relates to the surgical insertion device according to Example17, wherein the fluidic sealing component comprises a sealable sleevedevice, a flexible seal component, a removable lid seal component, or aflap seal component.

Example 19 relates to the surgical insertion device according to Example17, wherein the top cap comprises at least one of at least one threadedlumen, a detachable cable harness, and a clamp projection.

Example 20 relates to the surgical insertion device according to Example17, further comprising at least one measurement mechanism coupled to thetop cap or the incision port.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, theinvention is capable of modifications in various obvious aspects, allwithout departing from the spirit and scope of the present invention.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view of an external pressurized system or apparatus,according to one embodiment.

FIG. 1B is a perspective view of the external pressurized system orapparatus of FIG. 1A with a surgical device positioned therein.

FIG. 2A is an exploded side view of the external pressurized system orapparatus of FIG. 1A.

FIG. 2B is an exploded perspective view of the external pressurizedsystem or apparatus of FIG. 1A.

FIG. 3A is an exploded side view of a top cap, according to oneembodiment.

FIG. 3B is an exploded perspective view of the top cap of FIG. 3A.

FIG. 4A is an exploded perspective view of a port, according to oneembodiment.

FIG. 4B is an exploded side view of the port of FIG. 4A.

FIG. 5A is an upper perspective view of a base ring and port ring,according to one embodiment.

FIG. 5B is a lower perspective view of the base ring and port ring ofFIG. 5A.

FIG. 6A is a top schematic view of a sealable sleeve device beingpositioned in an incision, according to one embodiment.

FIG. 6B is a top schematic view of the sealable sleeve device of FIG. 6Abeing positioned in an incision, according to one embodiment.

FIG. 6C is a top schematic view of the sealable sleeve device of FIG. 6Abeing positioned in an incision, according to one embodiment.

FIG. 6D is a top schematic view of the sealable sleeve device of FIG. 6Abeing positioned in an incision, according to one embodiment.

FIG. 7A is a side view of a fully assembled port, according to oneembodiment.

FIG. 7B is a perspective view of the fully assembled port of FIG. 7A.

FIG. 8A is a side view of the coupling of a canister and connector ring,according to one embodiment.

FIG. 8B is a side view of the coupling of the canister and connectorring of FIG. 8A.

FIG. 9 is a side view of an external pressurized system or apparatuswith a surgical device positioned therein, according to one embodiment.

FIG. 10 is a perspective view of the external pressurized system orapparatus of FIG. 9, in which the surgical device has been urged out ofthe system or apparatus and into the patient's cavity.

FIG. 11 is a perspective view of the external pressurized system orapparatus of FIG. 10, in which the canister has been removed.

FIG. 12 is a perspective view of an balloon seal insertion system orapparatus, according to one embodiment.

FIG. 13A is a perspective view of an balloon seal insertion system orapparatus, according to one embodiment.

FIG. 13B is an exploded perspective view of the balloon seal insertionsystem or apparatus of FIG. 13A.

FIG. 14A is a perspective view of a port housing, according to oneembodiment.

FIG. 14B is a cutaway perspective view of the port housing of FIG. 14A.

FIG. 14C is a cutaway perspective view of the port housing of FIG. 14A.

FIG. 15 is a perspective view of a standard sealable sleeve device,according to one embodiment.

FIG. 16A is a cutaway side view of a balloon seal insertion system orapparatus, according to one embodiment.

FIG. 16B is a cutaway perspective view of the balloon seal insertionsystem or apparatus of FIG. 16A.

FIG. 17A is a cutaway perspective view of a balloon seal insertionsystem or apparatus with a first arm of a surgical device disposedtherethrough, according to one embodiment.

FIG. 17B is a cutaway perspective view of the balloon seal insertionsystem or apparatus of FIG. 17A in which the first arm is positionedusing a connection rod.

FIG. 18 is a cutaway perspective view of a rubber seal access/insertiondevice, according to one embodiment.

FIG. 19A is an exploded side view of a rubber seal access/insertiondevice, according to one embodiment.

FIG. 19B is an exploded perspective view of the rubber sealaccess/insertion device of FIG. 19A.

FIG. 20 is an exploded perspective view of the separate rubber seals ofa rubber seal access/insertion device, according to one embodiment.

FIG. 21 is a top view of a rubber seal access/insertion device,according to one embodiment.

FIG. 22 is a base ring of a rubber seal access/insertion device,according to one embodiment.

FIG. 23 is a side view of a rubber seal access/insertion device,according to one embodiment.

FIG. 24A is a side view of an external pressurized system or apparatushaving one or more additional access ports, according to one embodiment.

FIG. 24B is another side view of the external pressurized system orapparatus of FIG. 24A.

FIG. 24C is a top view of the external pressurized system or apparatusof FIG. 24A.

FIG. 24D is a perspective view of the external pressurized system orapparatus of FIG. 24A.

FIG. 24E is another top view of the external pressurized system orapparatus of FIG. 24A.

FIG. 24F is a cutaway side view of the external pressurized system orapparatus of FIG. 24A along the cross-section shown with the dotted linein FIG. 24E.

FIG. 25 is a perspective view of an access port with a hand disposedtherethrough, according to one embodiment.

FIG. 26 is a top view of another access port, according to anotherembodiment.

FIG. 27A is a perspective view of a port adaptor ring coupling an accessport to a tube, according to one embodiment.

FIG. 27B is a perspective view of a device access port having a deviceattachment component, according to one embodiment.

FIG. 28A is a perspective view of a glove port, according to oneembodiment.

FIG. 28B is a perspective view of the glove port in FIG. 28A in use.

FIG. 29A is a top schematic view of a sealable sleeve device beingpositioned in an incision, according to one embodiment.

FIG. 29B is a top schematic view of the sealable sleeve device of FIG.29A being positioned in an incision, according to one embodiment.

FIG. 30 is a cutaway side view of an incision port, according to oneembodiment.

FIG. 31A is a top view of a base ring of an incision port, according toone embodiment.

FIG. 31B is a perspective view of the base ring of FIG. 31A.

FIG. 32 is a perspective view of a tube bracket, according to oneembodiment.

FIG. 33 is a perspective view of a tube bracket coupling a main tube toa base ring, according to one embodiment.

FIG. 34 is a perspective view of a sleeve clamp, according to oneembodiment.

FIG. 35 is a cutaway side view of an incision port, according to oneembodiment.

FIG. 36 is a perspective view of an incision port with an internalcoupling component, according to one embodiment.

FIG. 37A is a cutaway side view of an incision port coupled to a portseal, according to one embodiment.

FIG. 37B is a cutaway perspective view of the incision port and the portseal of FIG. 37A.

FIG. 37C is a perspective view of the underside of a base seal ring,according to one embodiment.

FIG. 38A is a cutaway side view of an incision port having a flap sealcomponent, according to one embodiment.

FIG. 38B is a cutaway side view of an incision port having a flap sealcomponent and coupled to a port seal, according to one embodiment.

FIG. 38C is a perspective top view of the incision port and a port sealof FIG. 38B.

FIG. 39A is a perspective side view of an external pressurized device,according to another embodiment.

FIG. 39B is a perspective side view of the external pressurized deviceof FIG. 39A.

FIG. 40 is a side view of an external pressurized device having twoslots, according to a further embodiment.

FIG. 41A is a side view of a positioning tube, according to oneembodiment.

FIG. 41B is a top view of the positioning tube of FIG. 41A.

FIG. 42 is a perspective view of a stacked incision port, according toone embodiment.

FIG. 43 is a perspective view of an incision port having two seals,according to one embodiment.

FIG. 44 is a perspective view of an incision port having two seals,according to another embodiment.

FIG. 45A is a top view of an incision port, according to a furtherembodiment.

FIG. 45B is a perspective view of the incision port of FIG. 45A.

FIG. 46A is a top view of an air barrier incision port system, accordingto one embodiment.

FIG. 46B is a top view of the air barrier port of the port system ofFIG. 46A.

FIG. 47 is a perspective side view of a rubber seal incision port,according to one embodiment.

FIG. 48A is a perspective side view of a dual brush incision port,according to one embodiment.

FIG. 48B is another perspective side view of the dual brush incisionport of FIG. 48A.

FIG. 49A is a perspective top view of a triple brush incision port,according to one embodiment.

FIG. 49B is a perspective side view of the triple brush incision port ofFIG. 49A.

FIG. 50A is a side view of an insertion device, according to oneembodiment.

FIG. 50B is another side view of the insertion device of FIG. 50A.

FIG. 50C is another side view of the insertion device of FIG. 50A.

FIG. 51A is a side view of an insertion device, according to anotherembodiment.

FIG. 51B is a top view of the insertion device of FIG. 51A.

FIG. 52 is a side view of an insertion device, according to a furtherembodiment.

FIG. 53 is a side view of a surgical device positioned in a positioningrod, according to one embodiment.

FIG. 54A is a side view of an internal pressurized bag device, accordingto one embodiment.

FIG. 54B is another side view of the internal pressurized bag device ofFIG. 54A.

FIG. 55 is a side view of another external pressurized system orapparatus, according to one embodiment.

FIG. 56A is a perspective side view of a top cap, according to oneembodiment.

FIG. 56B is another perspective side view of the top cap of FIG. 56A.

FIG. 57A is a perspective side view of a top cap and a canister,according to one embodiment.

FIG. 57B is another perspective side view of the top cap and canister ofFIG. 57A.

FIG. 58A is a perspective view of a top cap with a portion of a deviceassembly positioned therethrough, according to one embodiment.

FIG. 58B is a perspective view of the underside of the top cap of FIG.58A.

FIG. 59A is a perspective view of a top cap with a portion of a deviceassembly positioned therethrough, according to one embodiment.

FIG. 59B is a another perspective view of the top cap of FIG. 59A.

FIG. 60 is a cutaway perspective view of a top cap, according to oneembodiment.

FIG. 61A is a perspective side view of a top cap coupled to a canisterwith a portion of a device assembly positioned therethrough, accordingto one embodiment.

FIG. 61B is another perspective side view of the top cap of FIG. 61A.

FIG. 62A is a perspective side view of a base coupling component,according to one embodiment.

FIG. 62B is another perspective side view of the base coupling componentof FIG. 62A.

FIG. 63A is a perspective side view of a base coupling component and anaccess port, according to one embodiment.

FIG. 63B is another perspective side view of the base coupling componentand the access port of FIG. 63A.

FIG. 63C is a perspective side view of a portion of the base couplingcomponent and the access port of FIG. 63A.

FIG. 63D is another perspective side view of a portion of the basecoupling component and the access port of FIG. 63A.

FIG. 63E is a cutaway side view of the base coupling component and theaccess port of FIG. 63A.

FIG. 64A is side view of an external pressurized system or apparatuswith a base coupling component and access port, according to oneembodiment.

FIG. 64B is a top view of the external pressurized system of FIG. 64A.

FIG. 65A is a side view of an external pressurized system or apparatuswith a base coupling component and access port, according to oneembodiment.

FIG. 65B is another side view of the external pressurized system orapparatus of FIG. 65A.

FIG. 66A is a side view of an external pressurized system or apparatuswhen the robotic device is lowered through an opening created by anaccess port, according to one embodiment.

FIG. 66B is another side view of the external pressurized system orapparatus of FIG. 66A.

FIG. 67A is a side view of an external pressurized system or apparatusin which the forearms of the robotic device are positioned at an angleof or near 45° in relation to the upper arms, according to oneembodiment.

FIG. 67B is another side view of the external pressurized system orapparatus of FIG. 67A.

FIG. 68A is a side view of an external pressurized system or apparatusin which the forearms of the robotic device are positioned in aparticular position, according to one embodiment.

FIG. 68B is another side view of the external pressurized system orapparatus of FIG. 67A.

FIG. 69A is a side view of an external pressurized system or apparatusin which the forearms of the robotic device are positioned in anappropriate starting position for a procedure, according to oneembodiment.

FIG. 69B is another side view of the external pressurized system orapparatus of FIG. 67A.

FIG. 70 is a side view of an external pressurized system or apparatushaving a flexible container, according to another embodiment.

FIG. 71A is a perspective side view of a base coupling component,according to one embodiment.

FIG. 71B is another perspective side view of the base coupling componentof FIG. 71A.

FIG. 72A is a perspective side view of a port attachment having aremovable lid and an access port, according to one embodiment.

FIG. 72B is another perspective side view of the port attachment andaccess port of FIG. 72A.

FIG. 73A is a perspective side view of a port attachment having aremovable lid and an access port, according to one embodiment.

FIG. 73B is another perspective side view of the port attachment andaccess port of FIG. 73A.

FIG. 74A is a cutaway side view of a port attachment having a removablelid and an access port, according to one embodiment.

FIG. 74B is another cutaway side view of the port attachment and accessport of FIG. 74A.

FIG. 75A is a perspective side view of an external pressurized insertiondevice having a port attachment with a removable lid, according to oneembodiment.

FIG. 75B is another perspective side view of the external pressurizedinsertion device of FIG. 75A.

FIG. 75C is another perspective side view of the external pressurizedinsertion device of FIG. 75A.

FIG. 76 is a perspective side view of a top cap having a pressure reliefvalve, according to one embodiment.

FIG. 77A is a perspective side view of a top cap having a pressurerelief valve and port seal, according to one embodiment.

FIG. 77B is a perspective cutaway view of the top cap of FIG. 77A.

FIG. 78A is a side view of an insertion device having an actuator andsensor package.

FIG. 78B is another side view of the insertion device of FIG. 78A.

FIG. 78C is another side view of the insertion device of FIG. 78A.

FIG. 79 is a side cutaway view of an insertion device having ameasurement mechanism associated with the top cap, according to oneembodiment.

FIG. 80 is a side cutaway view of an incision port of an insertiondevice having a measurement mechanism associated with the incision port,according to one embodiment.

FIG. 81 is a top view of a top cap of an insertion device having astring measurement system, according to one embodiment.

FIG. 82A is a top view of a top cap of an insertion device having asubstantially rigid structure measurement mechanism, according to oneembodiment.

FIG. 82B is an underside view of the top cap of FIG. 82A.

FIG. 82C is an underside view of an incision port of the insertiondevice of FIG. 82A.

FIG. 82D is a perspective view of the substantially rigid structurehaving a pegged ball of the insertion device of FIG. 82A.

FIG. 82E is a top view of the incision port of FIG. 82C.

FIG. 83 is a cutaway side view of an incision port having aninsufflations port, according to one embodiment.

FIG. 84A is a cutaway side view of an insertion device having aspherically shaped canister, according to one embodiment.

FIG. 84B is a cutaway side view of an insertion device having aconically shaped canister, according to one embodiment.

FIG. 85A is a cutaway side view of an insertion device having a canisterwith vertical rib structures, according to one embodiment.

FIG. 85B is a cutaway side view of an insertion device having a canisterwith horizontal rib structures, according to one embodiment.

FIG. 85C is a cutaway side view of an insertion device having a canisterwith spiral-shaped rib structures, according to one embodiment.

FIG. 86A is a side view of a base coupler that can be releasably coupledto a canister, according to one embodiment.

FIG. 86B is another side view of the base coupler and canister of FIG.86A.

FIG. 86C is another side view of the base coupler and canister of FIG.86A.

FIG. 86D is another side view of the base coupler and canister of FIG.86A.

FIG. 87A is a perspective side view of a top cap and outer handle set,according to one embodiment.

FIG. 87B is a cutaway side view of the top cap and outer handle set ofFIG. 87A.

FIG. 87C is a perspective cutaway view of the top cap and outer handleset of FIG. 87A.

FIG. 88A is a side view of an insertion device, according to oneembodiment.

FIG. 88B is a perspective view of a top cap of the insertion device ofFIG. 88A.

FIG. 88C is a perspective view of a mobile seal and outer handle set ofthe insertion device of FIG. 88A.

FIG. 88D is a perspective view of an incision port of the insertiondevice of FIG. 88A.

FIG. 89 is a side view of an insertion device having a substantiallynon-flexible canister portion and a substantially flexible canisterportion, according to one embodiment.

DETAILED DESCRIPTION

The various embodiments described herein relate to systems, devices,and/or methods for accessing an insufflated cavity of a patient and/orpositioning surgical systems or devices into the cavity.

Certain embodiments provide for insertion of the surgicalsystems/devices into the cavity while maintaining sufficientinsufflation of the cavity. Further embodiments minimize the physicalcontact of the surgeon or surgical users with the surgicaldevices/systems during the insertion process. Other implementationsenhance the safety of the insertion process for the patient and thesystems/devices. For example, some embodiments provide visualization ofthe system/device as it is being inserted into the patient's cavity toensure that no damaging contact occurs between the system/device and thepatient. In addition, certain embodiments allow for minimization of theincision size/length. Further implementations reduce the complexity ofthe access/insertion procedure and/or the steps required for theprocedure. Other embodiments relate to devices that have minimalprofiles, minimal size, or are generally minimal in function andappearance to enhance ease of handling and use.

It is understood that any of the various embodiments disclosed hereincould also be automated or made into fully automatic devices/systems andthus could be used by lightly-trained users, such as on the battlefieldor during a space mission or the like.

One embodiment relates to an external pressurized system or apparatus.For example, one implementation of an external pressurized system orapparatus 10 is depicted in FIG. 1A. The apparatus 10 has a canister 12with a top cap 14 coupled to a top portion 16 of the canister 12. Inthis embodiment, the canister 12 has a port 18 that is coupled to thecanister 12 at a base portion 20 of the canister 12. The port 18 ispositioned in an incision in the skin 22 of the patient, therebyproviding access to a cavity 24 of the patient. As shown in FIG. 1B, theapparatus 10 is configured to receive a surgical device 26 such that thedevice 26 can be inserted into the patient cavity 24 through the port 18of the apparatus 10.

In one implementation, the canister 12 is made of a hard plastic, suchas, for example, poly(methyl methacrylate) (“PMMA”). Alternatively, thecanister 12 can be made of any known rigid material that can be used inmedical devices. It is understood that certain embodiments of thecanister 12 are transparent, such as those depicted in the figuresprovided. The transparent canister 12 allows for the user to see thesurgical device 26 during insertion. Alternatively, the canister 12 isnot transparent and the device 26 can be inserted without being able toview the device 26 in the canister 12.

FIGS. 2A and 2B provide an exploded view of the external pressurizedapparatus 10 according to one embodiment. As discussed above, the topcap 14, also depicted in FIGS. 3A and 3B, is coupled to the top portion16 of the canister 12. The top cap 14 has a seal 30 that is held inplace with a cover 32. According to one implementation, the cover iscoupled to the top cap 14 with bolts, other similar mechanicalfasteners, or any other known mechanism, device, or method for couplingtwo such components together.

In one implementation as best shown in FIGS. 2B and 3B, the seal 30 hasan orifice 34 defined in the seal 34. As best shown in FIG. 1B, theorifice 34 is configured to receive a positioning rod 28, as describedin further detail below. In one embodiment, the seal 30 is made of sometype of rubber. Alternatively, the seal 30 can be made of any number ofknown materials that can be used to provide a fluid seal around a smoothrod, including a gel material or the like. In a further alternative, thetop cap 14 can have any known configuration that provides a seal havingan orifice or other type of access for a positioning rod 28 or the like.

As best shown in FIGS. 2A, 2B, 4A, and 4B, the port 18 (also referred toherein as an “incision port”), in accordance with one implementation,has multiple components. In this particular embodiment, the port 18 hasa connector ring 40, a base ring 42, a port ring 44, and a sealablesleeve device 46. The sealable sleeve device 46 has an upper sleeve ring46A and a lower sleeve ring 46B, both of which are coupled together by aflexible sleeve 46C. In certain embodiments, the flexible sleeve 46C haselastic properties. As best shown in FIGS. 5A and 5B, the port ring 44has multiple teeth or protrusions 44A defined in a top portion of thering 44 in a circular configuration around a hole 50. In addition, inone embodiment, the ring 44 has a lip 52 extending from the bottomportion of the ring 44 and defining an outer edge of the hole 50. Asdescribed below, this lip 52 can be positioned within the incision madein the patient, thereby defining the smallest circumference of theincision. Further, the port ring 44 has three guide projections 54extending from the top portion of the ring 44, which can aid in keepingthe base ring 42 positioned appropriately when it is placed on top ofthe port ring 44 as described below. In addition, according to oneembodiment, the port ring 44 can also have indentations 60 around itscircumference that allow a user to grasp the port ring 44 during use asdescribed below. Alternatively, the port ring 44 can have any exteriorfeature or mechanism that a user can use to better grasp the ring 44.

As also shown in FIGS. 5A and 5B, the base ring 42 has an underside thathas multiple indentations 42B defined in the ring 42. In one embodiment,the indentations 42B correspond to the protrusions 44A in the port ring44 such that the base ring 42 and port ring 44 can be coupled androtational force can be transferred from one to the other, as describedin further detail below. Alternatively, the features on the base ring 42and the port ring 44 can be ridges that can easily couple together. In afurther alternative, the features can be any known features or physicalcomponents that can be coupled together to allow for transmission ofrotational force as described herein. In addition, as best shown in FIG.5B, the underside of the base ring 42 has an exterior lip or ridge 62,according to one embodiment. When the base ring 42 is in contact withthe port ring 44, the ridge 62 is in slidable contact with the port ring44. In one implementation, the contact of the ridge 62 with the portring 44 can provide a better seal that the ridges 42B, 44A providealone. As such, this seal can be a secondary seal that can actually bestrengthened as the sleeve device 46 is rotated and the two rings 42, 44are urged together.

The connector ring 40 is configured to be coupleable with the canister12, as will be described in further detail below. In addition, theconnector ring 40 is coupleable to the rest of the port 18 by beingconfigured to be coupleable to the base ring 42. In one embodiment, asbest shown in FIG. 2B, the connector ring 40 has multiple threaded holes40A defined through the ring 40 that correspond to multiple threadedholes 42A defined through the base ring 42, such that screws, bolts, orthe like can be inserted into and through the threaded holes 40A, 42A ofthe two rings 40, 42, thereby coupling the two rings 40, 42 together.Alternatively, any known coupling components or methods can be used tocouple the two rings 40, 42.

The base ring 42 is coupleable to the port ring 44. When the base ring42 is placed on and in contact with the top of the port ring 44, theprotrusions 44A are positioned in the indentations 42B and rotationalfriction is established such that any rotational force applied to thebase ring 42 will be transmitted to the port ring 44 (or vice versa)without any slippage between the two rings 42, 44. Further, the basering 42 and port ring 44 are coupled such that the holes 48, 50 in eachring 42, 44 correspond as well. Alternatively, any known couplingcomponents or methods can be used to couple the two rings 42, 44 in thesame fashion.

In use, the external pressurized system 10 can be used to insert asurgical device or system into a cavity of a patient. One method ofinsertion will now be described, but it is understood that theembodiments disclosed herein are not limited to a single procedure andinstead can be used in any procedure that falls within the spirit of thevarious implementations contemplated herein.

In one embodiment, the port 18 is placed in an incision in the followingmanner to create a seal for the incision that fluidly seals thepatient's cavity from the ambient air outside the patient. First, anincision is made in the patient that provides access to the patient'starget cavity. In one embodiment, the cavity is the peritoneal cavity,but the target could be any known cavity. Once the incision has beenmade, the sealable sleeve device 46 is positioned in the incision, forexample as shown in FIGS. 6A, 6B, 6C, and 6D. In this embodiment, thedevice 46 is positioned through incision 58. The device 46 is positionedin the incision by inserting the lower sleeve ring 46B (not shown inFIGS. 6A-6D) through the incision 58 such that the lower ring 46B ispositioned within the patient and the upper ring 46A is positionedoutside the patient, with the sleeve 46B extending through the incision58. According to one embodiment, the lower sleeve ring 46B of the device46 is a flexible ring 46B that can be deformed such that the ring 46Bcan be inserted through the incision 58.

In one embodiment, prior to positioning the sealable sleeve device 46 inthe incision 58 as described above, the device 46 is first positioned ina similar fashion through the hole 50 in the port ring 44 and the hole48 in the base ring 42. That is, the lower sleeve ring 46B is deformedand inserted through the hole 50 and the hole 48, thereby resulting inthe upper sleeve ring 46A being positioned on the top portion of thebase ring 42 (which is positioned on the top portion of the port ring44) and the lower sleeve ring 46B being positioned on the bottom portionof the port ring 44. The lower sleeve ring 46B is then inserted throughthe incision 58 in the patient as described above. Alternatively, thesealable sleeve device 46 can be positioned through the hole 50 in theport ring 44 and the hole 48 in the base ring 42 after the device 46 hasbeen positioned through the incision 58.

Once the lower ring 46B is inserted through the incision 58 as shown inFIG. 6A and further positioned in the hole 50 in the port ring 44, theupper ring 46A is positioned over the incision 58 such that the incision58 is centered within the ring 46A, as shown in FIG. 6B. For ease ofunderstanding, the port ring 44 is not depicted in these figures. Thesealable sleeve 46 is then tightened to create a seal and position thelower ring 46B snugly to the underside of the incision 58 and the upperring 46A snugly to the top portion of the base ring 42. This tighteningoccurs by rotating the upper ring 46A. In one embodiment, the upper ring46A is less flexible (more rigid) than the lower ring 46B, therebyallowing a user to grasp it and rotate it. FIG. 6C depicts the sealablesleeve device 46 after the ring 46A has been rotated, thereby causingthe sleeve 46C to gather and begin to close the opening in the sleeve46C (or “collapse on itself”). FIG. 6D shows the sleeve device 46 afterthe user has successfully rotated the ring 46A to the point that a sealis formed in the sleeve 46C by closing the opening therein.

It is understood that the base ring 42 and the port ring 44 are intendedto be generally rotatable relative to each other during the process ofpositioning the port 18 and thereby sealing the incision 58. That is,when the base ring 42 is initially positioned on the port ring 44, thetwo rings 42, 44 are rotatable in relation to each other. This relativerotation of the two rings 42, 44 allows for rotation of the sleevedevice 46, thereby resulting in the seal created by the sleeve device 46when it is sufficiently constricted. However, when the sleeve device 46,the port ring 44, and the base ring 42 are positioned in the incision 58and the sealable sleeve device 46 is tightened to close the hole in theincision 58 as described above, the elasticity of the sleeve 46C urgesthe base ring 42 and port ring 44 together as described above, causingthe bottom surface of the base ring 42 and the top surface of the portring 44 to come into contact such that the ridges 44A on the port ring44 couple with the ridges 42B on the base ring 42 as described above.The interfacing ridges 44A, 42B provide an interface or coupling thatwill result in rotational coupling of the rings 42, 44 when the ringsare in contact, but also is releasable when desired. It is understoodthat the more force applied to urge the two rings 42, 44 together (themore that the sleeve device 46 is rotated), the more secure the couplingof the ridges 44A, 44B becomes.

Once the sleeve device 46, the port ring 44, and the base ring 42 arepositioned in the incision 58 as described above, the connector ring 40is coupled to the base ring 42. In one embodiment as described above,the connector ring 40 is coupled to the base ring 42 via nuts or bolts.Alternatively, any standard coupling device or method can be used. Oncethe connector ring 40 is coupled to the base ring 42, the port 18 isfully assembled, as shown in FIGS. 7A and 7B.

According to one embodiment, the coupling of the connector ring 40 tothe base ring 42 as shown in FIG. 7A, in combination with the tighteningof the sleeve device 46 as described above, creates a fluid seal thatseals the patient's cavity from the ambient air outside the patient.More specifically, at this point the sealable sleeve device 46 providesa seal as best shown in FIG. 6D. One of ordinary skill in the artunderstands that this fluidic seal is sufficient to maintain theincreased air pressure of the insufflated cavity of the patient.

Once this seal is established, the canister 12 with the medicaldevice/system 26 positioned inside can be coupled to the connector ring40 as best shown in FIG. 1B such that the device/system 26 can then beinserted into the insufflated cavity 24 of the patient. Prior to thatcoupling, the device/system 26 (coupled to a positioning rod 28) must bepositioned in the canister 12. While it is understood that any number ofknown procedures within the spirit of the embodiments contemplatedherein could be used to position the device/system 26 in the canister12, one implementation provides for—prior to coupling the canister 12 tothe port 18—inserting the device/system 26 through the open end (notshown) at the base portion 20 of the canister 12 (as best depicted inFIG. 1A) and inserting the positioning rod 28 through the orifice 34defined in the seal 30 in the top cap 14. It is understood that thepositioning rod 28, in accordance with some embodiments, can have one ormore lumens therein that can contain one or more connection components(such as wires, cords, or the like) that connect the device/system 26 toan external controller of some kind, thereby allowing for the controllerto control the device/system 26 via the connection component(s).

Once the device/system 26 is positioned in the canister 12 with thepositioning rod 28 extending out of the top cap 14 through the orifice34 in the seal 30 as best shown in FIG. 1B, the canister 12 can becoupled to the connector ring 40. In one embodiment as best shown inFIGS. 8A and 8B, the base portion 20 of the canister 12 has at least 2projections 12A extending from the canister 12 that correspond to theslots 40B in the connector ring 40. More specifically, in theimplementation depicted in FIGS. 8A and 8B, the canister 12 has 4projections 12A (one of which is not shown) that correspond to 4 slots40B in the connector ring 40. To couple the canister 12 to the ring 40,the four projections 12A are inserted into the slots 40B and thecanister 12 is rotated in a counterclockwise fashion to position theprojections 12A in the fully coupled position in the slots 40B as shownin FIG. 8B. Alternatively, any known coupling mechanism, device, orprocedure can be used to couple the canister 12 to the ring 40.

Once the canister 12 is coupled to the port 18 as best shown in FIG. 9,a seal has been achieved that fluidically separates and seals fluidwithin the canister 12 from fluid outside the canister 12. At thispoint, the pressure inside the canister 12 is increased until it matchesthe pressure of the insufflated cavity 24. By equalizing the pressure inthe canister 12 to the pressure in the insufflated cavity 24, thedevice/system 26 positioned in the canister 12 can then be inserted intothe cavity 24 through the seal created by the sealable sleeve device 46without causing a loss of pressure or loss of insufflation in the cavity24. According to one embodiment, the fluidic seal is maintained in thecanister 12 by the seal created between the canister 12 and the port 18and further by the seal created between the positioning rod 28 and theseal 30. More specifically with respect to the positioning rod 28 andthe seal 30, it is understood that the rod 28 is sized to contact theinner circumference of the orifice 34 in the seal 30, thereby resultingin an airtight fluidic seal between the rod 28 and the seal 30. It isunderstood that, at this point, if a user wants to adjust thepositioning of the device/system 26, the user can do so using thepositioning rod 28.

Once the air pressure in the canister 12 is substantially the same asthe air pressure in the insufflated cavity 24, the device/system 26 ismoved out of the canister 12, through the port 18 and the incision 58,and into the patient's cavity 24. According to one embodiment as bestshown in FIG. 1B, the device/system 26 can be moved through the port 18and into the cavity 24 using the positioning rod 28, which is coupled atits distal end to the device/system 26. That is, a user can grasp aproximal end of the rod 28 and move the rod 28 in a distal direction asdesired to move the device/system 26 distally out of the canister 12 andinto the cavity 24. In those implementations in which the device/systemis a robotic device having operational arms, the device, including thearms, can be advanced through the port 18 and into the insufflatedcavity 24. It is understood that the user can also turn the rod 28 toturn the device/system 26 as needed/desired as well. In this fashion,the user can position the device/system 26 as desired within thepatient's cavity 24 in order to perform a procedure.

In alternative embodiments, the positioning rod 28 can be a larger rodthan that depicted in these figures such that the rod 28 can havemultiple lumens defined within the rod 28, including one or more largerlumens that could be used for tool and/or camera insertion. Insufflationafter removal of the canister 12 could also be accomplished through sucha rod 28. In a further alternative, instead of a rod, a port such as aknown SILS port could be used.

Once the device/system 26 has been inserted into, and is positioned asdesired in, the patient's cavity 24, the fluidic seal is re-establishedbetween the insufflated cavity 24 and the interior of the canister 12via the sealable sleeve device 46. As a result, the pressure inside thecanister 12 can be lowered until it is substantially equal to theambient pressure. At that point, the canister 12 can be de-coupled fromthe connector ring 40. That is, according to one embodiment, thecanister 12 is rotated in the clockwise direction, thereby urging theprojections 12A out of the slots 40B in the ring 40. Once the canister12 is removed, as best shown in FIG. 11, only the port 18 itself remainswith the fluidic seal established by the combination of the port 18components, including the sealable sleeve device 46 as described above.Thus, the user can freely position and operate the device/system usingthe positioning rod 28 (and, in some embodiments, the externalcontroller (not shown) connected to the device/system via the connectioncomponent(s)). For example, the removal of the canister 12 can providefor additional accessibility and freedom of movement for the rod 28. Assuch, the medical procedure using the system/device 26 is typicallyperformed once the canister 12 is removed as shown in FIG. 11.

Another access and insertion embodiment relates to a balloon sealinsertion method and device for inserting a surgical device/system intoa patient's cavity and performing a surgical procedure using a balloonseal insertion device that operates to maintain a fluidic seal aroundthe surgical device such that the higher air pressure of the insufflatedcavity is not lost during the procedure. One example of a balloon sealinsertion device 100 being used to position and operate a surgicaldevice 102 in a patient's insufflated cavity 106 is depicted in FIG. 12.As depicted, the insertion device 100 is positioned on the patient'sskin (schematically depicted as 106) and through the incision in theskin (not shown). The connecting rod 104 coupled to the device 102 ispositioned through the insertion device 100, with the surgical device102 positioned within the patient's insufflated cavity 108.

As best shown in FIGS. 12, 13A, and 13B, the insertion device 100 canmaintain a fluidic seal during a surgical procedure because the device100 has an expandable seal 114 (also referred to as an “expandableballoon” or “balloon” herein) disposed through a hole 112 defined in theport housing 110 of the device 100. The balloon 114 provides a fluidicseal around any surgical device positioned through the hole 112 becausethe balloon 114 is flexible, expandable, and elastic. As such, as theballoon 114 is inflated, it provides “odd geometry molding,” which meansit can be expanded around, come into contact with, and conform to theshape of any object positioned through the hole 112, thereby creating afluidic seal around that object, regardless of its shape.

As best shown in FIG. 13B, the insertion device 100 comprises a porthousing 110 that defines a hole 112 as discussed above. As alsodiscussed above, the balloon 114 is positioned within the hole 112. Thehousing 110 further has two balloon inflation/deflation ports 116A, 116Band a cavity insufflation/deflation port 118. In addition, the housing110 has two attachment components 120 configured to allow for theattachment of the coupling components 122. The coupling components 122are used to couple the housing 110 to a standard sealable sleeve 46 aswill be discussed below.

The ports 116A, 116B, 118 are configured to receive various types ofstandard valves and/or connections such as Luer locks, each of which isconfigured to provide an interface for external tubes, hoses, or thelike for providing inflation or deflation as desired/needed. In thisspecific embodiment, two connections 124, 126 are Luer locks and oneconnection 128 is a Schrader valve. According to one implementation, aSchrader valve is used for connection 128 in port 116B to accommodateconnection to a standard air pump while also providing a release valveto deflate the balloon seal 114 when necessary. It is understood thatany other known valves or connections used with medical devices—such as,for example, any connections using standard UNF or NPT size fittings—canbe used in place of connections 124, 126, 128 with variousimplementations of this device 100.

It is understood that the various ports 116A, 116B, 118 are intended tocouple to external hoses, tubes, or the like, one or more of which arein turn coupled to external air pressure sources. It is furtherunderstood that one or all of the external air pressure sources can bean insufflation device or an air pump typically used for inflation of amedical device. In one embodiment, the external air pressure source is aself-regulating device that self-regulates the level of the airpressure. Alternatively, the external air pressure source can be anyknown air pressure source that is used with inflatable medical devices.

According to one embodiment, the balloon 114 has a top ring 140, abottom ring 144, and an expandable body 142 connecting the two rings140, 144. It is understood that these parts of the balloon 114 can bepart of a single integral piece that makes up the balloon 114.Alternatively, the balloon 114 can be made up of separate components.The top ring 140 is positioned on and coupled to the top lip 130 on thetop portion of the hole 112, while the bottom ring 144 is positioned onand coupled to the bottom lip 132 on the bottom portion of the hole 112,as best shown in FIGS. 14B and 14C. In accordance with oneimplementation, the rings 140, 144 can be coupled to the lips 130, 132chemically (a glue or other type of adhesive) or mechanically (clamps,screws, or any other known mechanical attachment mechanisms).Alternatively, the expandable seal 114 can be any known expandabledevice or component that is used with medical devices and can provide afluidic seal via odd geometry molding. In one embodiment, the balloon114 is comprised of latex or some type of rubber. Alternatively, theballoon 114 can be made of any known material used in medical devicesthat is expandable, elastic, and can provide a fluidic seal via oddgeometry molding.

In one implementation, the thickness of the seal 114 can be modified toinfluence how the seal 114 operates. For example, various parts of theseal 114 can have different thicknesses to influence the way in whichthe seal 114 expands when it is inflated. Alternatively, the seal 114can have a single thickness that can be varied to influence theresistance of the seal 114 when an object is inserted through it.Alternatively, the thickness can be varied for other reasons as well. Ina further alternative embodiment, in addition to at least one expandableelastic material, an additional material or materials can be added tothe seal 114. For example, a fabric or other type of material that isless elastic and/or less expandable can be included in the seal 114 toinfluence or control the way the seal 114 expands when it is inflated.For example, a fabric could be included in a top and bottom portion ofthe seal 114 to prevent the seal 114 from expanding vertically (up ordown) and thereby influence the seal 114 to expand horizontally.

In the embodiment as shown, the attachment components 120 are threadedholes configured to receive screws or bolts or the like. Further, inthis implementation, the threaded holes 120 are positioned on oppositesides of the housing 110. Alternatively, any appropriate knownattachment component 120 can be used to allow for attachment of thecoupling components 122 to the housing 110. Further, it is understood byone of ordinary skill that the number and positioning of the attachmentcomponents 120 on the housing can vary as desired to allow for differentconfigurations and different types of coupling components 122.

FIGS. 14A, 14B, and 14C depict additional details about theconfiguration of the port housing 110, according to one embodiment. Morespecifically, as best shown in FIG. 14B (which depicts a cross-sectionof the housing 110), the port housing 110 has two ballooninflation/deflation lumens 150A, 150B defined in the housing 110. Theballoon inflation/deflation lumen 150A provides a fluid connectionbetween the balloon inflation/deflation port 116A and the hole 112,thereby allowing for inflation or deflation of the expandable seal 114via the port 116A. Similarly, the balloon inflation/deflation lumen 150Bprovides a fluid connection between the balloon inflation/deflation port116B and the hole 112, thereby also allowing for inflation or deflationof the expandable seal 114 via the port 116B.

As best shown in FIG. 14C (which depicts a different cross-section ofthe housing 110), the port housing 110 also has a cavityinsufflation/deflation lumen 152 defined in the housing 110 thatprovides a fluid connection between the cavity insufflation/deflationport 118 and patient's cavity 108 which is in fluid communication withthe underside of the housing 110 when the housing is positioned on theincision in the patient. This lumen 152 thus allows for insufflation ordeflation of the patient's cavity 108 via the port 118.

In use, the device 100 is positioned on the incision 160 in the patientin combination with a standard sealable sleeve device 162 as best shownin FIGS. 16A and 16B. The standard sealable sleeve device 162 is shownin FIG. 15. It has an upper ring 164 and a lower ring 166 that arecoupled together by a flexible sleeve 168. According to one embodiment,the device 162 is substantially similar to the sealable sleeve devicedescribed above with respect to FIGS. 2A, 2B, 6A, 6B, 6C, and 6D.

In one implementation, the sealable sleeve device 162 is firstpositioned in the incision 160. It is understood that the sleeve device162 can be inserted using steps similar to those described above.Alternatively, any known insertion steps can be used to insert thedevice 162 into the incision such that the upper ring 164 is positionedoutside of the incision 160 and the lower ring 166 is positioned insidethe patient's cavity, with the sleeve 168 disposed through the incision160 itself, as best shown in FIG. 16A.

Once the sleeve device 162 is positioned in the incision 160, thehousing 110 is coupled to the sleeve device 162 as best shown in FIGS.16A and 16B. More specifically, according to one implementation, thehousing 110 is positioned over the upper ring 164 of the sleeve device162 such that the upper ring 164 is positioned into the circularindentation or notch 170 defined in the bottom of the housing 110. Theconfiguration of the notch 170 corresponds to the configuration of theupper ring 164 and thus is configured to receive the upper ring 164 suchthat the ring 164 fits snugly into the notch 170.

Once the ring 164 is positioned in the notch 170, the couplingcomponents 122 are coupled to the attachment components 120 on thehousing 110 and thereby firmly couple the housing 110 to the sleevedevice 162. The coupling components 122 in this embodiment arecomponents having a vertical piece 122A and a horizontal piece 122B. Thevertical pieces 122A are coupled to the attachment components 120 usinga screw or bolt or similar mechanism. As best shown in FIG. 16 a, whenthe vertical pieces 122A are coupled to the attachment components 120,the horizontal pieces 122B are positioned under the housing 110 suchthat they are also positioned under the upper ring 164 disposed in thenotch 170. As such, the coupling components 122 operate to retain orlock the upper ring 164 in the notch 170. As a result, the retention ofthe upper ring 164 into the notch 170 can provide a fluidic seal betweenthe housing 110 and sleeve device 162. Alternatively, any appropriateknown interface between the housing 110 and sleeve device 162 thatprovides a fluidic seal can be used.

Once the housing 110 and sleeve device 162 are coupled, the balloon 114can be inflated using either port 116A or port 116B or both. When theballoon 114 has been sufficiently inflated such that the expandable body142 of the balloon 114 contacts itself, a fluidic seal is createdbetween the patient's cavity and the ambient air outside the patient'sbody. Once this fluidic seal is established, the patient's cavity 108can be insufflated using port 118 to the desired pressure inside thecavity 108 and the appropriate devices and/or instruments can beinserted into the cavity 108 through the expanded balloon 114 seal withloss of pressure inside the cavity 108.

In one particular example as depicted in FIGS. 17A and 17B, adevice/system having two robotic arms 180, 182 are positioned in thepatient's cavity 108 through the expanded balloon 114 seal. Morespecifically, the first robotic arm 180 is inserted into the expandedballoon 114 seal in FIG. 17A. Due to the odd geometry formation of theexpanded balloon 114, the fluidic seal is maintained even as the firstarm 180 is being inserted through the balloon 114. Once the first arm180 is successfully inserted into the cavity 108 and positioned asdesired as shown in FIG. 17B using a connection rod 184, the second arm182 is inserted into the balloon 114 seal. Again, the odd geometryformation of the balloon 114 allows this to occur without losing thefluidic seal and thus without losing the higher pressure of theinsufflated cavity 108.

Returning to FIG. 12, this figure depicts a final position of therobotic system having two arms 180, 182. With the arms 180, 182positioned as desired, the system can now be operated by a user orsurgeon to perform the desired procedure.

It is contemplated that alternative embodiments of the balloon sealdevices could have more than one balloon seal provided in a singledevice. Those two or more balloon seals could be provided in variousconfigurations. For example, in one configuration, in addition to thecentral seal similar to that described above, a second seal could beprovided off to one side of the first seal and positioned at an angle sothat any device or object inserted through the second seal would beinserted at an angle. It is understood that these two or more balloonseals could be pneumatically connected to the same air pressuresource(s), or, alternatively, each seal could be pneumatically separateso that each has its own pressure source and can be set at its ownindependent level of air pressure.

Another access and insertion embodiment relates to a rubber sealinsertion method and device for inserting a surgical device/system intoa patient's cavity and performing a surgical procedure using a rubberseal access/insertion device that operates to maintain a fluidic seal atthe incision such that the higher air pressure of the insufflated cavityis not lost during the procedure. One example of a rubber sealaccess/insertion device 200 is depicted in cross-sectional view in FIG.18. As depicted, the access/insertion device 200 is positioned on thepatient's skin (schematically depicted as 202) over the incision 206 inthe skin 202 and is coupled to a standard sealable sleeve device 204,which is disposed through the incision 206.

As best shown in FIGS. 19A and 19B, the access/insertion device 200 hasa base ring 210 that is coupleable to the sleeve device 204. The device200 also has three seals 212A, 212B, 212C positioned between the basering 210 and the first top ring 214. In some embodiments, the device 200has only the first set of seals (212A, 212B, 212C) and the first topring 214. In alternative embodiments such as the implementation asshown, the device 200 also has a second set of three seals 216A, 216B,216C positioned between the first top ring 214 and a second top ring218. In this implementation, the first and second top rings 214, 126 arecoupled to the base ring 210, thereby maintaining the first set of seals212A, 212B, 212C and second set of seals 216A, 216B, 216C in place suchthat each of the sets of seals 212, 216 and the two top rings 214, 218maintain a fluidic seal. According to one embodiment, a set of screws orbolts are positioned through the holes 210A, 214A, 218A defined in theouter circumference of each of the base ring 210, the first top ring214, and the second top ring 218, respectively, and fastened to fix therings 210, 214, 218 in place. Alternatively, any known device ormechanism for holding or fixing the rings 210, 214, 218 (and thus theseals 212, 214) in place can be used.

According to one embodiment, the fluidic seal created by the set ofseals (212A, 212B, 212C, for example) is created by providing separaterubber seals having different types of openings defined in each suchseal. For example, as best shown in FIG. 20, in this implementation, theseals 212A, 212B, 212C each have two different openings formed throughthem that are different from the corresponding openings in the otherseals. Seal 212A has two substantially circular holes 230A, 230B formedthrough the seal 212A. The hole 230A is larger, is positioned morecentrally on the seal 212A, and is intended to receive a surgical deviceor system such as a robotic surgical device. The hole 230B is smaller,is positioned closer to an edge of the seal 212A, and is intended toreceive a peripheral device or component such as a trocar, a camera, orsome other accessory tool. These holes 230A, 230B are intended toprovide a fluidic seal around the perimeter of any object(s) passedthrough them.

In contrast, seal 212B has two slits 232A, 232B formed through the seal212B. The slit 232A is larger and is positioned in a location thatcorresponds to hole 230A, while slit 232B is smaller and is positionedin a location that corresponds to hole 230B. Similarly, seal 212C has alarger slit 234A positioned in a location corresponding to hole 230A andslit 232A and further has a smaller slit 234B positioned in a locationcorresponding to hole 230B and slit 232B. In addition, the slits 234A,234B in seal 212C are positioned at a 90 degree angle with respect tothe slits 232A, 232B in seal 212B. According to one implementation, thecombination of the slits 232A, 232B in seal 212B with the slits 234A,234B in seal 212C results in a stronger fluid seal that can withstandthe increased pressure of the insufflated cavity 208 of the patientwithout the slits opening and allowing that increased pressure to belost.

By incorporating two sets of seals 212, 216 as shown in FIGS. 19A, 19B,the overall fluidic seal created by the device 200, even when surgicaldevices are inserted through the device 200, is further strengthened.More specifically, as best shown in FIG. 19B, the first top ring 214defines a hole 214B at its center. When the first top ring 214 ispositioned between the first set of seals 212 and the second set ofseals 216, the hole 214B in the first top ring 214 creates a cavitybetween the two sets of seals 212, 214. As such, according to oneembodiment, any loss of the fluidic seal in one set of the seals (either212 or 214) will not cause a loss of the overall fluidic seal or leakpressure directly from the patient's cavity 208 into the ambient airoutside the patient. Hence, the cavity created by the first top ring 214can minimize the overall pressure loss from any such leak.

In accordance with one implementation, each of the seals 212A, 212B,212C, 216A, 216B, 216C is a relatively thin sheet of rubber.Alternatively, each of the seals can be made of any known flexiblematerial that can serve as a seal in a medical device. In one exemplaryembodiment, each of the seals is about 0.125 inches thick.Alternatively, the thickness of each of the seals can vary between about0.0625 and about 0.25 inches thick. In a further alternative, each setof three seals 212, 216 can be replaced with a single seal having athickness ranging from about 0.1875 inches to about 0.75 inches. Thisthickness in a single seal, according to some embodiments, can providesubstantially the same type of fluidic seal strength as the set of threethin seals.

As discussed above, according to certain embodiments, the device 200 hasonly one set of seals 212A, 212B, 212C and only the first top ring 214.While such embodiments do not have the cavity created by the first topring 214 as described above, the device 200 with a single set of seals212 can still provide a sufficient fluidic seal. For example, such adevice 200 would provide a sufficient fluidic seal for insertion of anyrobotic device having sufficiently smooth external features andsurfaces. In addition, a device 200 with a single set of seals 212 canreduce the size of the overall device 200 and can potentially reduce anytrauma to the surgical device inserted through the device 200 as aresult of only having to pass through a single set of seals 212.

FIG. 21, according to one implementation, depicts a top view of thedevice 200. More specifically, FIG. 21 shows the second top ring 218positioned over the seal 216A. The holes 236A, 236B in the seal 216A arevisible as well.

In use, the rubber seal access/insertion device 200 can be positionedfor use in the following manner. First, as described above with respectto other embodiments, according to one implementation, the sealablesleeve device 204 is first positioned in the incision 206. It isunderstood that the sleeve device 204 can be inserted using stepssimilar to those described above. Alternatively, any known insertionsteps can be used to insert the device 204 into the incision such thatthe upper ring 240 is positioned outside of the incision 206 and thelower ring 242 is positioned inside the patient's cavity, with thesleeve 244 disposed through the incision 206 itself, as best shown inFIG. 18.

Once the sleeve device 204 is positioned in the incision 206, the basering 210 (and thus the entire device 200) is coupled to the sleevedevice 204 as best shown in FIGS. 18 and 22. More specifically,according to one implementation, the base ring 210 is positioned overthe upper ring 240 of the sleeve device 204 such that the upper ring 240is positioned into the circular indentation or notch 250 defined in thebottom of the base ring 210. The configuration of the notch 250corresponds to the configuration of the upper ring 240 and thus isconfigured to receive the upper ring 240 such that the ring 240 fitssnugly into the notch 250.

Once the upper ring 240 is positioned in the notch 250, the couplingcomponents 220 are coupled to the attachment components 252 on the basering 210 and thereby firmly couple the base ring 210 to the sleevedevice 204. The coupling components 220 in this embodiment arecomponents having a vertical piece 220A and a horizontal piece 220B asbest shown in FIG. 19A or 22. The vertical pieces 220A are coupled tothe attachment components 252 using a screw or bolt or similarmechanism. As best shown in FIG. 18, when the vertical pieces 220A arecoupled to the attachment components 252, the horizontal pieces 220B arepositioned under the base ring 210 such that they are also positionedunder the upper ring 240 disposed in the notch 250. As such, thecoupling components 220 operate to retain or lock the upper ring 240 inthe notch 250. As a result, the retention of the upper ring 240 into thenotch 250 can provide a fluidic seal between the base ring 210 andsleeve device 204. Alternatively, any appropriate known interfacebetween the base ring 210 and sleeve device 204 that provides a fluidicseal can be used.

Once the device 200 and sleeve device 204 are coupled as best shown inFIGS. 18 and 23, a fluidic seal has been established between thepatient's cavity 208 and the external air outside of the patient. Atthis point, the patient's cavity can be insufflated to the desiredamount of air pressure. Subsequently, one or more surgical devices canbe inserted through the seals 212, 216 at the appropriate holes/slitsand into the patient's insufflated cavity 208. In one embodiment, eacharm of a robotic surgical device can be separately and consecutivelyinserted through the larger hole (and larger slits) of the seals andinto the cavity 208. Alternatively, any known devices can be insertedinto the cavity 208 so long as they fit through the holes and slits ascontemplated herein.

Another embodiment of an access/insertion device relates to anotherexternal pressurized system or apparatus similar to the system orapparatus depicted in FIGS. 1-11 and described in detail above. Like thedevice in FIGS. 1-11, the instant device is coupled to a port that ispositioned over and/or in an incision in the skin of the patient,thereby providing access to a cavity of the patient. However, in theinstant implementations as shown in FIGS. 24A-38 and discussed below,the external pressurized system/apparatus has a external body having oneor more access ports for the insertion of not only surgical devices, butalso additional equipment and/or the hands of one or more users ormedical professionals, providing access to the interior of thepressurized system/apparatus without loss of the higher pressure insidethe system/apparatus.

For example, one implementation of such an external pressurized systemor apparatus 300 is depicted in FIGS. 24A-24F. As best shown in FIGS.24C (top view) and 24D (perspective view), the device 300 has anexternal body 302 having a main tube (also referred to as the“canister”) 304, a left hand tube 306 with a left hand access port 308,a right hand tube 310 with a right hand access port 312, and a sideaccess tube 314 with a side access port 316. In addition, the main tube304 has a device port 318 coupled to a top portion of the tube 304.

The bottom portion of the main tube 304 is coupleable to an incisionport 320, as best shown in FIGS. 24A and 24B. In turn, as best shown inFIG. 24F, the incision port 320 is coupleable to a standard sealablesleeve device 322, which can be positioned in the incision 324 made inthe patient's skin 326 to access a target cavity 328 of the patient. Theincision port 320 and its coupling to both the main tube 304 and thesealable sleeve device 322 are described in detail below.

In the depicted implementation, the left and right hand access ports308, 312 can be configured to allow a user or medical professional toinsert her or his hands through the ports 308, 312 and into the interiorof the body 302. Further, the side access tube 314 with access port 316can be used for storage of equipment and/or for assistance of anotheruser by inserting her or his hand through the port 316. In addition, thedevice access port 318 can be configured such that various medicaldevices/systems can be inserted into the body 302 through the port 318.Alternatively, any of the access ports 308, 312, 316, 318 can beconfigured to allow for insertion of hands and/or equipment/devices.Further, in various alternative embodiments, it is understood that thebody 302 could have a main tube 304 with one, two, or more than threeadditional tubes with access ports for various uses, including any ofthose discussed above. It is also understood that various embodimentscontemplated herein include tubes and/or ports that are different sizesor shapes than those depicted. For example, in some implementations, thetubes and/or ports could be square or oval in shape.

In one implementation, the external body 302 (the main tube 304 and theaccess tubes 306, 310, 314) is made of a hard plastic, such as, forexample, poly(methyl methacrylate) (“PMMA”). Alternatively, the body 302can be made of any known rigid material that can be used in medicaldevices. It is understood that certain embodiments of the body 302 aretransparent, such as those depicted in the figures provided. Thetransparent body 302 allows for the user to see the interior of thetubes 304, 306, 310, 314 including any equipment or devices beinginserted during the procedure. Alternatively, the body 302 is nottransparent and the equipment/devices can be inserted without being ableto view them in the device 300.

According to one implementation, the sealable sleeve device 322, as bestshown in FIGS. 24F, 29A, 29B, and 30, can be a standard, commerciallyavailable device as described in the various embodiments above. Thedevice 322 has an upper ring 420 and a lower ring 422 that are coupledtogether by a flexible sleeve 424. According to one embodiment, thedevice 322 is substantially similar to the sealable sleeve devicedescribed above with respect to FIGS. 2A, 2B, 6A, 6B, 6C, and 6D.

According to one embodiment, the access ports 308, 312, 316, 318 arestandard commercially-available ports that allow various objects,including devices or hands, to be inserted through them and into asurgical space. One example of an access port 340 in use is depicted inFIG. 25. As shown in that figure, the port 340 allows for insertion of ahand through the port 340. Another exemplary access port 342 is depictedin FIG. 26. This port 342 is the GelSeal® port that is commerciallyavailable from Applied Medical in Rancho Santa Margarita, Calif. In thisembodiment, the port 342 has a body 344, a rigid support ring 346, and amoveable clamp lever 348 that can be used to tighten the port 342 andthus secure the port 342 to any ringed object to which it is attached.More specifically, the clamp lever 348 is depicted in three differentpositions. In position A, the lever 348 is in the open position A andthe port 342 thus has its widest circumference. In position B, the lever348 is midway between the open position A and the closed position C andthe port 342 has a circumference that is less than when it is in theopen position A. Finally, in position C, the lever 348 is positionedagainst the port 342 in the closed position C and the port 342 has itssmallest circumference. In use, the lever 348 is typically in position Awhen the port 342 is positioned and then the lever 348 is moved toposition C to clamp the port 342 in place. In one embodiment, the body344 is made of the soft, gel-like material in the product as provided byApplied Medical. Alternatively, the body 344 can be made of any materialthat allows for objects and/or hands to be inserted through the materialsuch that the fluidic seal is maintained so that the higher pressure ofthe surgical cavity is not lost when an object is inserted through thematerial.

In accordance with one implementation as shown in FIG. 27A, the accessports 308, 312, 316, 318 are coupled to the tubes 304, 306, 310, 314 viaa port adaptor ring 350. The port adaptor ring 350 has a first ringportion 352 that is sized to mate with any one of the tubes 304, 306,310, 314 of the body 302. (In this particular depiction, the left handaccess tube 306 is used as an example.) The ring 350 also has a secondring portion 354 that is sized to mate with a port—in this case the lefthand access port 308.

According to one embodiment, the first ring portion 352 is coupled tothe tube 306 by positioning the first ring portion 352 over the end ofthe tube 306 and holding the first ring portion 352 in place using thumbscrews 356 that are inserted through threaded holes 358A in the firstring portion 352 and into threaded holes 358B in the tube 306.Alternatively, any attachment devices or mechanisms, such as bolts,clamps, or the like, can be used to attach the first ring portion 352 tothe tube 306 (and, by extension, to any of the tubes 304, 306, 310,314). In one embodiment, a gasket (not shown), such as a foam or rubbergasket, is positioned between the tube 306 and the first ring port 352to ensure that a fluidic seal is established between the two components.

The access port 308, in accordance with one implementation, is coupledto the second ring portion 354 in a fashion similar to that describedabove. That is, the clamp lever 308A on the port 308 is placed inposition A, and the port 308 is positioned over the second ring portion354. Then the lever 308A is moved into the closed position—positionC—such that the port 308 is clamped onto the second ring portion 354.Alternatively, any known mechanism or method for coupling a port similarto port 308 to a device component can be used.

According to one embodiment as shown in FIG. 27B, the device access port318 can have one or more additional structures to allow a user to easilystabilize or position a surgical device within the body 302 of thedevice 300 prior to or during use. More specifically, the device accessport 318 in certain implementations has one or more device attachmentcomponents 357 (also referred to as “device clips”) positioned along theinner lumen of the port 318. The device clip 357 is configured to retaina device such as a positioning rod 359 within the clip 357, therebyproviding a way to couple a portion of the surgical device being usedfor the intended procedure to the interior of the body 302. In oneembodiment, the attachment component 357 is an actual clip as shown inFIG. 27B. Alternatively, the component 357 can be a notch or other typeof specifically configured indentation 357 defined in the inner lumen ofthe port 318 that is configured to receive a medical device such as apositioning rod 359 or the like. In a further alternative, theattachment component 357 can be any mechanical or structural mechanismor component that allows for coupling to a medical device. In furtherembodiments, such attachment components 357 can be positioned elsewherein the body 302, such as, for example, on an interior port of anotheraccess port or elsewhere on an interior portion of one of the tubes.

In various alternative embodiments, other types of access ports can beused instead of the ports described above and depicted in FIGS. 24-27B.For example, in one specific alternative implementation, one or moreglove ports can be used such as the glove port 360 depicted in FIGS. 28Aand 28B. The glove port 360 has a glove component 362 coupled to a gloveport ring 364. In various embodiments, the glove port 360 could becoupled at the glove port ring 362 to one or more of the tubes 304, 306,310, 314 on the body 302. In one embodiment, the glove port ring 362 iscoupled to the tube via a clamp lever similar to the clamp leverdescribed with respect to FIG. 26. Alternatively, any known couplingmechanism can be used. Unlike the access ports 308, 312, 316, 318, theglove port 360 does not require that a fluidic seal be establishedaround the surgeon's arm or whatever object is inserted through it. Assuch, the glove port 360 can help to ensure that the pressuredifferential between the patient's cavity and the ambient air outsidethe patient will be maintained. In one embodiment, the glove port 360has a pressure relief valve (not shown) that can be used to adjust thevolume, thereby accounting for the volume change caused when a userinserts her or his hand into the body 302 using the glove component 362.FIG. 28B depicts the glove port 360 in use.

As mentioned above, the incision port 320 is configured to be coupleableto both the main tube 304 and to the sealable sleeve device 322, asshown in FIGS. 24F and 29. As best shown in FIGS. 24A and 30, theincision port 320 has a base ring 370. The upper portion of the basering 370 can be coupled to an internal coupling component 372, which cancouple to the port seal 450 as described in further detail below.Further, the lower portion of the base ring 370 can be coupled toexternal coupling components 374 (also referred to in certainembodiments as “sleeve clamps”), which couple the ring 370 to thesealable sleeve device 322. In addition, the base ring 370 can also becoupled to coupling components 376 (also referred to in certainembodiments as “tube brackets”), which couple the ring 370 to the maintube 304 of the device 300.

FIGS. 31A and 31B depict the base ring 370, according to oneimplementation. The ring 370 has a curved indentation or notch 378configured to receive and couple with the bottom portion of the maintube 304. In addition, the ring 370 has three bracket receivingcomponents 380 configured to receive the tube brackets 376. Further, asbest shown in FIGS. 24F, 30, and 35, the bottom portion of the ring 370defines a circular indentation or lumen 381 that is configured to bepositioned over and receive the upper ring 420 of the sleeve device 322.The ring 370 also has multiple holes 384 defined in an interior ring382. The multiple holes 384 correlate to holes 436 in the base plate 430of the internal coupling component 372, as described in detail below.Each of the bracket receiving components 380 have a projection 386 andhorizontal portion 388 on which the tube bracket 376 is positioned and ahole 390 that corresponds to the hole 394 in the tube bracket 376 asdescribed in detail below. In one embodiment, a gasket (not shown), suchas a silicon, foam or rubber gasket, is provided between the notch 378and the bottom portion of the main tube 304 to strengthen the fluidicseal between the two components.

FIG. 32 depicts a tube bracket 376, according to one embodiment. Thetube bracket 376 has a base portion 392 having a hole 394 definedtherein that corresponds to the hole 390 in the bracket receivingcomponent 380 on the base ring 370. The bracket 376 also has a tubecontacting portion 396 having two holes 398 defined therein thatcorrespond to the holes 404 in the bottom portion of the main tube 302,as described below.

According to one embodiment, the tube bracket 376 is used to couple themain tube 302 to the base ring 370, as shown in FIG. 33. Morespecifically, the tube bracket 376 is positioned on the bracketreceiving components 380, with the base portion 392 of the bracket 376positioned on the horizontal portion 388 and the tube contacting portion396 positioned on the projection 386. In that position, the bracket 376is coupled to the base ring 370 by inserting a threaded screw 400through hole 394 in the bracket 376 and into hole 390 in the ring 370.Further, the bracket 376 is coupled to the main tube 302 by insertingtwo threaded screws 402 through holes 398 in the bracket 376 and intoholes 404 in the tube 302. Thus, the tube 302 is attached in positionagainst the incision port 320 and specifically the base ring 370 usingthe brackets 376. In the embodiments depicted in FIGS. 24A-24F, thereare three tube brackets 376—spaced about 120 degrees from each otheraround the circumference of the port 320—that are used to couple thetube 302 to the port 320. Alternatively, two brackets or more than threebrackets could be used in different positions around the port 320. In afurther alternative, any known type of coupling mechanism could be usedto keep the tube 302 coupled to the port 320.

As discussed above, the incision port 320 is coupled to the sealablesleeve device 322 using the sleeve clamps 374. FIG. 34 depicts oneembodiment of a sleeve clamp 374. The clamp 374 has a hole 406 definedin a top portion of the clamp 374, projections 408 configured to fitinto the notches 410 defined under the bracket receiving components 380on the base ring 370 (as best shown in FIG. 31B), and a projection 412configured to help retain the upper ring 420 of the sealable sleevedevice 322 in position on the clamp 374, as discussed below. The hole406 corresponds to the hole 394 in the bracket 376 and the hole 390 inthe base ring 370 such that when the sleeve clamp 374 is positionedunder the bracket receiving component 380 of the base ring 370 and thethreaded screw is inserted through hole 394 and hole 390, it is alsothreaded into hole 406 such that the sleeve clamp 374 is coupled to thebase ring 370.

As best shown in FIGS. 30 and 35, when the port 320 is positioned overthe sleeve device 322 such that the upper ring 420 is positioned withinthe lumen 381 on the bottom portion of the base ring 370, the sleeveclamp 374 can be coupled to the base ring 370 as described and the upperring 420 of the sealable sleeve device 322 is contacted by the clamp 374and thereby retained in its desired position as shown. Further, thenotch 412 in the clamp 374 can further help to retain the upper ring420. In one embodiment, a gasket (not shown), such as a foam, rubber, orsilicone gasket, is placed between the upper ring 420 and the undersideof the base ring 370, thereby providing a stronger fluidic seal betweenthe two components.

As discussed above, according to one embodiment, the upper portion ofthe base ring 370 can be coupled to an internal coupling component 372,as best shown in FIGS. 24A, 30, and 36. The internal coupling component372 has a base plate 430 and a male component 432 projecting from thebase plate 430. The base plate 430 has multiple holes 436 defined in theplate 430. These holes 436 correspond to the holes 384 defined in theinterior ring 382 of the base ring 370 such that screws 438 (or bolts orany other known coupling mechanisms) can be used to couple the baseplate 430 to the interior ring 382 of the base ring 370 as shown. Inaddition, the interior portion of the male component 432 has two deviceattachment components 440 (also referred to herein as “device clips”)(only one such clip 440 is shown in FIG. 36). Each device clip 440 isconfigured to be able to allow a user to couple a positioning rod (asdescribed elsewhere herein) or some other device component to the clip440 before or during a surgical procedure, thereby stabilizing ormaintaining the position of the device.

As best shown in FIG. 36, the male component 432 has three notches 434formed or engineered on its outer circumference (one of which is fullydepicted in FIG. 36). The notches 434 have a vertical portion 434A and ahorizontal portion 434B in communication with the vertical portion 434A.Each notch 434 is configured to received a corresponding projectionformed on an internal circumference of any device intended to couplewith the male component 432. As such, to couple the device to the malecomponent 432, the device is positioned over the male component 432 withthe projections on the device positioned over the corresponding notches434 on the male component 432. The device is then positioned onto themale component 432 such that each projection moves along the verticalportion 434A of the notch 434 until it reaches the horizontal portion434B. At that point, the device can be rotated and thereby move eachprojection circumferentially along the horizontal portion 434B of thenotch 434, thereby coupling the device to the male component 432 of theinternal coupling component 372.

In one implementation, as best shown in FIGS. 37A, 37B, and 37C, one ofthe components that can be coupled to the internal coupling component372 is a port seal 450. The port seal 450 has a seal clamp 452 coupledto a base seal ring 454. A seal component 456 is positioned between theclamp 452 and the ring 454 so that the coupling of the clamp 452 to thering 454 fixes the seal component 456 in place in the port seal 450. Inone embodiment as shown, the seal clamp 452 has multiple holes 458defined in the clamp 452 that correspond to holes (not shown) in thebase seal ring 454 such that threaded screws 460 (or bolts, or the like)can be inserted through the holes 458 and into the holes in the ring 454to couple the two components together. Alternatively, any other knownattachment mechanisms can be used. In one embodiment, a gasket (notshown), such as a foam, silicone, or rubber gasket, can be positionedbetween the male component 432 and the base seal ring 454 to strengthenthe fluidic seal between the two components.

The seal clamp 452, in one embodiment, has multiple projections 464extending from the top surface of the clamp 424. These projections 464can be easily grasped by a user to place the port seal 450 on the malecomponent 432 or remove it therefrom. Further, as best shown in FIG.37C, the underside of the base seal ring 454 has three projections 462disposed on the inner circumference of the ring 454. The threeprojections 462 correspond to the three notches 434 defined in the outercircumference of the male component 432 such that the base seal ring 454can be coupled to the male component 432 as described above.

According to one implementation, the seal component 456 (also referredto herein as a “flexible seal component” or an “elastic seal component”)is a circular sheet of flexible or elastic material that is configuredto allow a device or other equipment to be inserted through the sealcomponent 456 (or to allow the seal component 456 to be positioned oversuch equipment, like a positioning rod, as described in further detailbelow). In one embodiment, the seal component 456 is a circular rubbersheet having a small hole (not shown) in the sheet through whichequipment can be inserted. Alternatively, the seal component 456 can beany known material configured to maintain a fluidic seal when a deviceor equipment is inserted through the seal component 456.

In accordance with one embodiment, a different type of seal componentcan also be incorporated into the device 300. As shown in FIGS. 38A,38B, and 38C, a flap seal component 470 is provided. The flap sealcomponent 470 has two flaps—a first flap 472 and a second flap 474—thatcontact each other at a midpoint in the component 470. Each of the flaps472, 474 has ridges or teeth 472A, 474A on the surfaces that are incontact such that the ridges 472A on flap 472 correspond to the ridges474A on flap 474 and thus interface or couple with each other. In oneimplementation as shown, the flap seal component 470 is positionedbetween the base ring 370 and the internal coupling component 372.According to one implementation, the configuration of the flaps 472, 474extended downward toward the patient's cavity and the coupled ridges472A, 474A can provide structural strength to prevent a mechanicalfailure (also referred to as a “blowout”) in which the flaps 472, 474are forced outward by the higher air pressure until the flaps 472, 474are extending outward away from the patient's cavity and the fluidicseal is lost.

In one embodiment as shown in FIG. 38A, the flap seal component 470 canbe incorporated into the incision port 320 and used when the port seal450 is not coupled to the port 320. Alternatively, as shown in FIG. 38B,the flap seal component 470 can be incorporated into the incision port320 and used when the port seal 450 is coupled to the port 320.

In use, the various embodiments disclosed or contemplated hereinrelating to access and insertion systems, devices, and methods thatrelate specifically to an external device having one or more ports forthe insertion of not only medical devices, but also related equipmentand/or the hands of one or more medical professionals to access theinterior of the device during medical procedures while being able tomaintain a higher air pressure within the device that is substantiallythe same as the insufflated cavity of the patient. According to oneimplementation, the high pressure is around 18 mmHg above atmosphericpressure, which is around the amount of pressure that is used toinsufflate a patient's abdominal cavity during a laparoscopic procedure.Alternatively, any known higher pressure amount that is used duringmedical procedures can be used.

The method of using the device 300, according to one embodiment,includes at least some of the following steps. First, as described abovewith respect to other embodiments, according to one implementation, thesealable sleeve device 322 is first positioned in the incision 324 (seeFIGS. 24F, 29A, 29B, and 30). It is understood that the sleeve device322 can be inserted using steps similar to those described above.Alternatively, any known insertion steps can be used to insert thedevice 322 into the incision 324 such that the upper ring 420 ispositioned outside of the incision 324 and the lower ring 422 ispositioned inside the patient's cavity, with the sleeve 424 disposedthrough the incision 324 itself, as best shown in FIG. 30.

Next, the incision port 320 and the device 300 are coupled to thesealable sleeve device 322. As best shown in FIGS. 30, 33, and 35, thebase ring 370 of the incision port 320 is positioned over the upper ring420 of the sleeve device 322 such that the upper ring 420 is positionedin the lumen 381 on the bottom portion of the base ring 370. Inaddition, the bottom portion of the main tube 304 of the device body 302can be positioned in the curved notch 378 on the base ring 370. At thispoint, both the device 300 and the sleeve device are positioned asdesired with respect to the incision port 320 and must be coupled to theport 320. To do so, the tube brackets 376 and the sleeve clamps 374 arepositioned on the base ring 370 as described above and fixed in placeusing the threaded screws 400. Then the threaded screws 402 are placedas well. As such, the incision port 320 is coupled to both the device300 and the sleeve device 322 and a fluidic seal is created between theinterior of the body 302 and the exterior.

According to one embodiment, at least one medical device or piece ofequipment that will be used during the procedure can be placed in thebody 302 prior to coupling the body 302 to the incision port 320. Forexample, in one embodiment, the device 480 disposed within the body 302as best shown in FIGS. 24A, 24B, 24D, and 24F can be positioned withinthe body 302 and, in some implementations, secured to a device clip 357(as shown in FIG. 27B). More specifically, in the particular embodimentdepicted in FIGS. 24A, 24B, 24D, and 24F, the device 480 is made up oftwo arms 482A, 482B that are positioned within the body 302.Alternatively, any medical device that will be used for the surgicalprocedure could be positioned within the body 302 in the same or asimilar fashion.

It is understood, in accordance with one implementation, that the portseal 450 is not coupled to the internal coupling component 372 (which iscoupled to the incision port 320) at this point during the placement ofthe device 300. As such, according to one embodiment, the port seal 450is stored in the side access tube 314 while the body 302 is beingcoupled to the port 320, as best shown in FIGS. 24B, 24C, and 24D.Alternatively, the port seal 450 can be uncoupled from the internalcoupling component 372 and placed in the side access tube 314 prior topositioning the medical device inside the body 302 and coupling the body302 to the incision port 320.

Once the device 300 is coupled to the incision port 320 and the incisionport 320 is coupled to the sealable sleeve device 322, the fluidic sealwithin the device 300 has been established, and the patient's cavity canbe insufflated. This insufflation will result in an increase in airpressure within the patient's cavity and within the device 300 (becauseneither the port seal 450 nor the flap seal 470 is nt coupled to theinternal coupling component 372).

Once insufflation is achieved, the device 480 is positioned through theincision port 320 and into the patient's cavity. More specifically, theuser or medical professional inserts her or his hands into the left andright hand access ports 308, 312 and moves the medical device throughthe incision port 320 and into position within the cavity. At thispoint, if the medical device has a positioning rod 359, that rod 359 canbe coupled to a device clip 440 on the interior of the male component432 of the internal coupling component 372 of the port 320, therebyestablishing, maintaining, or fixing the position of the medical devicewithin the patient's cavity. Alternatively, the device can be positionedand maintained in that position using any type of mechanism or method,including some type of device or method independent of the device 300.

Once the medical device is positioned as desired, the port seal 450 canbe positioned in place over the device (or the positioning rod 359—orrods—of the device). That is, the user reaches in through the handaccess ports 308, 312 and removes the seal 450 from the side access tube314 and placed over the device/rod 359 so that the device and/or rod 359is inserted through the seal component 456 of the seal 450 and thencoupled to the male component 432 of the internal coupling component 372as described above.

Once the port seal 450 is in place, the body 302 can be removed from theincision port 320. More specifically, the user can remove the threadedscrews 402 and then remove the main tube 304 from the port 320. Thefluidic seal between the patient's cavity and the ambient air outsidethe patient's body is maintained by the port seal 450.

The user/medical professional can then begin performing the medicalprocedure.

An alternative external pressurized device embodiment is depicted inFIGS. 39A and 39B. In this embodiment, the device 500 is a single tube502 having a single access port 504 disposed at the top of the tube 502.The access port 504 serves to establish a fluidic seal when a medicaldevice or a surgeon's hand is inserted through the port 504. The tube502 also has two camera ports 506 extending from a bottom portion of thetube 502. According to one implementation, the tube 502 is configured tocouple to an incision port, including any incision port disclosedelsewhere herein or any known incision port.

A further embodiment depicted in FIG. 40 is another alternative externalpressurized device 510. The device 510 has a tube 514 that is coupleableto an incision port 516 and has two slots 511, 513 formed on oppositesides of the tube 514. These slots 511, 513 provide fluid communicationbetween the interior of the tube 514 and the exterior of the tube 514.In one embodiment, the rod slots 512 are each configured to receive apositioning rod. The device 510 further has two slot seals 512, with oneseal 512 positioned in each of the slots 511, 513. These slot seals 512are configured to maintain a fluidic seal at each of the slots 511, 513such that an object can be positioned through either or both slots 511,513 and the fluidic seal is not lost. The tube 514 also has two sets ofdevice attachment components 518A, 518B (also referred to as “rodclips”). Each set of rod clips 518A, 518B has two device clips—ahorizontal clip 515A and an angled clip 515B.

In use, a device can be positioned within the tube 514 such that apositioning rod coupled to the device extends out of the tube 514through one of the slots 511, 513. The device can be fixed in positionin the tube 514 by coupling the positioning rod to the horizontal clip515A. The patient's cavity can then be insufflated. When ready, thepositioning rod can be moved down the slot (511 or 513) such that thedevice is being moved down the interior of the tube 514 and insertedthrough the port 516 and into the patient's cavity. At this point, thepositioning rod is angled upward and clipped to the angled clip 515B,thereby fixing the positioning of the device inside the patient'scavity.

Another implementation relates to a positioning tube 520 as depicted inFIGS. 41A and 41B. In this embodiment, the positioning tube 520 can alsoact as a large positioning rod. The tube 520 has two guide slots 522defined in or attached to an inner portion of the tube 520. The guideslots 522 are each configured to receive a positioning rod 524. In thisimplementation, each device 526 (or device arm) is coupled to an end ofone of the positioning rods 524 and can be inserted through the tube 520and into the patient's cavity. Due to the size of the tube 520, thedevices 526 must be inserted one at a time. Alternatively, the tube 520can be sized so that both devices 526 can be inserted at the same time.The tube 520 also has an air lock 528 disposed in the tube 520. The airlock 528 is configured to be capable of fluidically dividing the tube520 into two fluidically separate compartments when the air lock 528 isclosed.

In use, the positioning tube 520 (having a robotic arm 526 disposedwithin the tube 520) can be inserted through any of the various incisionports described elsewhere herein. When the tube 520 is positioned sothat the distal end of the tube 520 is extending into the patient'scavity, a seal is created at the top of the top by placing a seal cap(not shown) on the top of the tube 520. Once the inside of the tube 520is sealed, the positioning rod 524 can be urged distally and thereby thearm 526 is urged out of the tube 520 and into the patient's cavity. If asecond arm 526 is going to be inserted, the air lock 528 is then closed.That is, the air lock 528 is closed to create a fluidic seal between thetop of the tube 520 and the bottom of the tube 520. Once the air lock528 is in place, the seal cap is removed, and the second arm 526 can bepositioned in the tube 520. At this point, the seal cap can be replaced,the air lock 528 can be released, and the second arm 526 can be insertedinto the patient's cavity.

Several additional embodiments relate to various types of incisionports. For example, FIG. 42 depicts a stacked incision port 540. Theport 540 actually has two access ports 542, 544 that are coupledtogether, with a cavity 546 between the two access ports 542, 544. Inone embodiment, the access ports 542, 544 are commercially availableGelSeal® ports. The cavity 546 between the two access ports 542, 544strengthens the overall fluidic seal of the port 540. In other words,the cavity 546 reduces the amount of air pressure loss because any airpressure loss is lost in the cavity and not lost to the ambient air,thereby reducing the overall loss.

Another incision port embodiment is depicted in FIG. 43. This incisionport 550 actually has two seals combined in the port: a rubber seal 552and a flap seal 554. The port 550 also has two camera ports 556extending out from the port 550. In one embodiment, the rubber seal 552has three different rubber disks (not shown) similar to the differentdisks depicted in FIG. 20 and described above. The disks in this rubberseal 552 can have openings/incisions that differ for each disk in thesame fashion as the disks shown in FIG. 20. Alternatively, the rubberseal 552 can be similar to any rubber or flexible seal describedelsewhere herein. The flap seal 554, according to one embodiment, issimilar to the flap seal depicted in FIGS. 38A-38C.

FIG. 44 depicts another incision port embodiment. More specifically,this port is a two-seal port 560 having a first rubber seal 562 and asecond rubber seal 564. The port 560 also has a base ring 570, a middlering 568, and a top ring 566. The middle ring 568 creates a cavity (notshown) between the two seals 562, 564 that is configured tocompartmentalize any lose of pressure by either of the seals 562, 564.The presence of the cavity makes this embodiment fairly similar to theincision port depicted in FIG. 42. According to one embodiment, eachsheet of rubber 562, 564 is about 0.5 inches thick and has a single slit(not shown) formed through the middle of it. Alternatively, each sheet562, 564 can have two openings (not shown) formed through the middle ofit.

FIGS. 45A and 45B depict a further incision port embodiment. This portis a three-sheet rubber seal port 580 having a single ring 582 in whichthree sheets of rubber (only the top sheet 584 is shown). In oneembodiment, each of the three sheets has an opening in it thatcorresponds to the openings in the other two sheets. In a furtherembodiment, the openings are similar to those depicted in FIG. 20 anddescribed. Alternatively, each sheet can have two correspondingopenings.

FIGS. 46A and 46B depict a further incision port system embodiment. Thissystem is an air barrier port system 590 having an air barrier port 592.This port 592 is coupled to four air tubes 596A, 596B, 596C, 596D thatare coupled to an air intake port 594. In operation, high pressure airis provided at the air intake port 594 and is forced through the fourtubes 596A-D and into the port 592. The four tube connections 598A,598B, 598C, 598D are positioned on the port 592 such that the air isforced into a channel (not shown) that encircles the hole 600 in theport 592. The air is then forced through a circular nozzle (not shown)in communication with the channel (not shown) that projects the air outof the nozzle and across the hole 600. The air flow projected across thehole 600, according to one implementation, is both directed and has ahigh velocity—both of which have an impact on the creation of an airbarrier. As a result, an air barrier is created in the hole 600 definedin the port 592. That is, the high velocity air movement across orwithin the hole 600 creates a fluidic seal that is sufficient tomaintain the insufflation of a patient's cavity.

FIG. 47 depicts another incision port embodiment—in this case, aone-sheet rubber seal port 610 having a single sheet of rubber 612(other flexible seal material) positioned between a base ring 614 and atop ring 616. In one embodiment, the sheet has slit (not shown) formedin it through which a surgical device or other equipment can beinserted. Alternatively, the sheet can have two slits or other types ofopenings.

Another incision port embodiment is shown in FIGS. 48A and 48B. Thisport is a dual brush port 620. This port 620 has a body 622 with a firstbrush holder 624 and a second brush holder 626. The first brush 628 ispositioned in the first brush holder 624 and the second brush 630 ispositioned in the second brush holder 626. Further, the body 622 has anopening 632 formed in a bottom portion of the body 622 that can provideaccess to the patient's cavity. The brush bristles of the two brushes628, 630 are mingled and meshed together at the brush seal 634 such thatthe mesh of bristles creates a fluidic seal that is sufficient tomaintain a patient's insufflated cavity.

FIGS. 49A and 49B depict another brush port—in this case, a triple brushport 640. This port 640 has a body 642 with first, second, and thirdbrush holders 644, 646, 648. The first brush 650 is positioned in thefirst brush holder 644, the second brush 652 is positioned in the secondbrush holder 646, and the third brush 654 is positioned in the thirdbrush holder 648. Further, the body 642 has an opening (not shown)formed in a bottom portion of the body 642 that can provide access tothe patient's cavity. The brush bristles of the three brushes 650, 652,654 are mingled and meshed together at the brush seal 656 such that themesh of bristles creates a fluidic seal that is sufficient to maintain apatient's insufflated cavity.

According to another implementation, FIGS. 50A, 50B, and 50C depict aninsertion device 670 that can be used to insert both arms of a roboticsurgical device into a patient's cavity. The insertion device 670 has aninsertion tube 672 through which an insertion rod 674 is slidablydisposed. In addition, the device has a first arm 676A and a second arm676B, both of which are coupled to the distal end of the tube 672. Thefirst arm 676A is coupled to an end bracket 680A coupled to an end ofthe first device body 682A, while the second arm 676B is coupled to anend bracket 680B coupled to an end of the second device body 682B.Further, the insertion rod 674 is coupled to two center brackets (onlybracket 678A is visible in the figures)—one center bracket 678A coupledto a middle portion of the first body 682A and a second center bracket(not shown) coupled to a middle portion of the second body 682B.

In use, the insertion device 670 can be used to insert a two-armedsurgical device through a hole (such as an incision, a port, or thelike) and into a patient's cavity prior to operating the device withinthe cavity. To accomplish this insertion, the insertion device 670initially maintains an insertion configuration (as best shown in FIG.50A) such that the surgical device has its smallest circumferentialprofile, thereby allowing it to pass through smaller holes. Once thesurgical device has been inserted into the patient's cavity, theinsertion device 670 can be moved into its deployed configuration (asbest shown in FIG. 50C) such that the surgical device is in itsoperational configuration. To accomplish this, a user or surgeonretracts the insertion rod 674 in a proximal direction (away from thesurgical device. This retraction of the rod 674 urges the two centerbrackets (with only center bracket 678A of body 682A depicted) in thesame proximal direction. Because the two end brackets 680A, 680B areretained in substantially the same position by the two arms 676A, 676B,the result is that the two device bodies 682A, 682B move through atransition depicted in FIG. 50B and into the operational configurationdepicted in FIG. 50C. At this point, the user or surgeon can use thesurgical device, including its two arms 684A, 684B to perform theplanned surgery or procedure.

There are numerous device access and insertion devices and methodsdisclosed in the instant application. All of the various devices andmethods that allow for access to a cavity and insertion of deviceshaving two arms can also generally be used with respect to devices thatcan be uncoupled into separate arms so as to allow each arm to beinserted individually. In one embodiment, one advantage of insertingeach arm separately is that inserting a first arm and then a second armin a serial manner (and possibly more arms) can likely be accomplishedthrough a smaller incision when compared to inserting both armssimultaneously.

FIGS. 51A and 51B depict an alternative embodiment of an insertiondevice 690 (in the same spirit as the insertion device depicted in FIGS.50A-C). While the above embodiment in FIGS. 50A-C depict an insertiondevice for use with a two-armed device, this insertion device 690 isused with a single arm 704 or with two arms that are insertedseparately. That is, in this embodiment, a single device arm 704 iscoupled to the insertion device 690. As shown, this device is positionedthrough an insertion tube 692 (which can also be a positioning orsupport rod). The device has two moveable rods 694, 696 slidablydisposed within the support rod 692. The first moveable rod 694 iscoupled at its distal end to a first robotic arm 704 and at its proximalend to a control lever 698. The second moveable rod 696 is coupled atits distal end to a coupling link 700 (that is coupled to the arm 704)and at is proximal end to a coupling link 702 (that is coupled to thelever 698).

In use, the lever 698 can be actuated to cause the first and second rods694, 696 to move in relation to each other. This movement of the rods694, 696 can be used to move the arm 704 and thereby position the arm704 as desired or needed inside the patient's cavity.

As shown in FIG. 51B, which is a cross-section of the support rod 692,showing that the support rod 692 can have two separate lumens 706, 708or slots, one for each of the moveable rods 694, 696. In one embodiment,the first moveable rod 694 is positioned in the first lumen 706 and thesecond moveable rod 696 is positioned in the second lumen 708.

In a further embodiment, it is understood that this support rod 692could have two halves—a right half 710 and a left half 712—that arecoupleable at the mating feature 714. Alternatively, the two halves canbe coupleable by any known mechanical means. The right half 710 isconfigured to hold the first and second rods 694, 696 relating to thefirst (or right) arm 704, while the left half is configured to hold thefirst and second rods 716, 718 relating to a second (or left) arm (notshown). This embodiment can thus be used with two arms, with each armbeing inserted and positioned separately.

FIG. 52 depicts another embodiment in which two separate arms can beinserted and positioned separately by using an overtube 722. In thisdevice 720, the first moveable rod 724 and second moveable rod 726 arestill positioned within a support rod 728. However, in this embodiment,the support rod 728 is positioned within an overtube 722. The overtube722 can be pass over the top of the support rod 728 in order to couplethe support rod 728 to a second support rod (not shown) or another halfof a support rod. This embodiment is another way to couple the twosupport rods or two halves of a support rod just as the mating feature714 accomplishes that task in the prior embodiment.

Of course, as shown in FIG. 53, in any embodiment in which the surgicaldevice or robotic arm has a motor 740 provided that can be positioned inthe positioning or support rod 744 and is coupled to the robotic arm742, there is no need for a separate insertion device. Instead, the arm742 can easily be positioned by actuating the motor 740 and transfer themotive force through the beveled gears 746 and to the arm 742.

FIGS. 54A and 54B depict a different type of access/insertion device incomparison to the devices described above. Unlike the above devices,which are generally incision ports or devices positioned outside thepatient's cavity, the internal pressurized bag device 750 shown in thesetwo figures is initially positioned in the patient's cavity. The device750 has a port seal 752, an outer sleeve 754, and an inner sleeve 756.The outer sleeve 754 is releasably sealed at the distal end 758. Thatis, the outer sleeve 754 has a releasable seal that can be intentionallybroken or released at a desired time during the procedure, as describedbelow.

In use, the entire device 750 can be positioned through an incision portsuch that the inner and outer sleeves 754, 756 are positioned inside thepatient's cavity with the port seal 752 coupled to the incision port(thereby creating a fluidic seal). Once the device 750 is positioned,the patient's cavity can be insufflated, and the outer sleeve 754 can bepressurized to a pressure that is greater than the pressure of theinsufflated cavity, thereby expanding the outer sleeve 754 to itsmaximum expansion (and, in some cases, making the outer sleeve 754substantially rigid). At this point, the surgical device can be insertedthrough the incision port and into the outer sleeve 754 and positionedas desired. At this point, the outer sleeve 754 can be removed byreleasing the releasable seal at the distal end of the sleeve 754. Thatis, the releasable seal could be a chemical seal such as an adhesivethat can be deactivated by applying a different composition to it.Alternatively, the releasable seal could be a mechanical release such asa pull cord or something of the like. In a further alternative, thereleasable seal could be any known mechanism or method for being able torelease the seal. Once the seal is released, the outer sleeve 754 can bepulled out of the cavity over the inner sleeve 756 and other componentsas best shown in FIG. 54B.

FIG. 55 depicts another implementation of an external pressurized systemor apparatus 800. The apparatus 800 has a container 802 with a top cap804 coupled to a top portion of the container 802. In this embodiment,the container 802 has a port 806 that is coupled to the container 802 ata base portion of the container 802. The port 806 is configured to bepositionable in an incision in the skin of the patient, therebyproviding access to a cavity of the patient. As shown in FIG. 55, theapparatus 800 is configured to receive a surgical device 808 such thatthe device 808 can be inserted into the patient cavity through the port806 of the apparatus 800.

According to one embodiment, in contrast to the canister 12 describedabove and depicted in FIGS. 1A-10, the container 802 in this device 800is made of a flexible material such as, for example, polyethyleneplastic, latex, nylon, or silicone rubber. As such, the container 802can be manipulated and configurable with respect to the shape of thecontainer 802, and more specifically can be compressed longitudinallysuch that the height of the container 802 can be reduced duringinsertion of a robotic device into a patient's cavity. This will bedescribed in further detail herein.

The top cap 804 is depicted in further detail in FIGS. 56A-61B. As shownin FIGS. 56A and 56B, the top cap 804 has a cap body 810, a detachablecable harness 812, an access lumen 814, support rod lumens 816, threadedlumens 818, and a clamp projection 820. The cap 804 has a notch 822defined in the cap 804 that is configured to receive the harness 812. Inaddition, the notch 822 has five channels 824A defined or formed in thenotch 822. The channels 824A match with the channels 824B defined in thedetachable harness 812 such that when the harness 812 is positioned inthe notch 822 and thus coupled with the cap body 810, the channels 824Aand the channels 824B match up to form lumens 824 as best shown in FIG.56B. In one implementation, the lumens 824 can be formed in differentsizes and configured to receive various cables and/or suction/irrigationtubes the extend from an external controller through the top cap 804 tothe surgical device 808.

In addition, the cap body 810 has a groove 826 formed or defined aroundthe outer edge of the body 810, including the outer edge of the harness812, such that when the harness 812 is coupled to the body 810, anO-ring can be positioned around the outer edge of the body 810 in thegroove 826.

FIGS. 57A and 57B depict the top cap 804 being coupled to the canister802. The flexible canister 802 is positioned over the peripheral edge ofthe body 810 as best shown in FIG. 57B and an elastic ring (alsoreferred to as an “O-ring”) 828 is positioned around the canister 802 atthe groove 826 such that a portion of the canister 802 is positionedbetween the body 810 and the ring 828 in the groove 826 and the ring 828urges the canister 802 into the groove 826, thereby creating a fluidicseal between the canister 802 and the top cap 804. Additionally, in onealternative embodiment, silicone sealant can be applied to the groove826 to enhance the strength of the fluidic seal. In accordance with oneimplementation, the O-ring 828 can also help to secure the cap body 810and the harness 812 together. In a further alternative, the O-ring 828can be any elastic member that can be used to maintain a fluidicallysealed coupling of the canister 802 and the top cap 804. In yet anotheralternative, any coupling mechanism can be used.

FIGS. 58A and 58B depict a portion of the device assembly 808 beingpositioned through the top cap 804. More specifically, the support rods830 coupled to the device 808 are slidably positioned through the lumens816 in the cap body 810. Further, according to one implementation, aportion of the device 808 also couples to or mates with the top cap 804.More specifically, a stabilization protrusion 832 on the device 808 iscoupleable with a mating hole 834 defined or formed in an underside ofthe body 810 as best shown in FIG. 58B. The positioning of thestabilization protrusion 832 in the mating hole 834 creates a pathwayfrom lumen 814 into and through the stabilization protrusion 832,thereby allowing for passage of additional tools or cameras through thedevice 800 without losing pressure.

As shown in FIGS. 59A, 59B, and 60, the top cap 804 is coupled to thesupport rods 830 with two threaded set screws 840. The set screws 840are threaded through lumens 818 as best shown in FIG. 59B. Morespecifically, the set screws 840 can be screwed into the threaded lumens818 until the screws 840 contact the support rods 830. The set screws840 are configured to exert pressure on the support rods 830, therebycreating frictional resistance that helps to secure the support rods 830and thus the device 808 to the top cap 804.

As best shown in FIG. 60, a connection cable 842 that is coupled at itsdistal end to the robotic device 808 is positioned through one of thelumens 824. It is understood that other cables can be positioned throughthe additional lumens 824 as well. In accordance with one embodiment,the cables are positioned in the channels 824A or 824B prior to couplingthe harness 812 to the body 810. Alternatively, one or more of thecables can be inserted through one of the lumens 824 after the body 810and harness 812 are coupled together.

FIGS. 61A and 61B show the container 802 coupled to the top cap 804.

FIGS. 62A and 62B depict the base coupling component (also referred toas the “base coupler”) 850 that is coupled to a bottom portion of thecontainer 802. The base coupler 850 has an upper groove 852, a lowergroove 854, and three coupling protrusions (also referred to as“coupling notches”) 856 that extend from a portion of the coupler 850between the upper and lower grooves 852, 854.

Like with the top cap 804 described above, the container 802 is coupledto the base coupler 850 using an O-ring 858. More specifically, thecontainer 802 is positioned over the upper portion of the coupler 850such that the container 802 is positioned over the upper groove 852 andadjacent to or against the three protrusions 856. The O-ring 858 ispositioned over the container 802 at the upper groove 852 such that theO-ring 858 urges a portion of the container 802 into the groove 852,thereby creating a fluidic seal between the container 802 and the basecoupler 850.

FIGS. 63A, 63B, 63C, 63D, and 63E depict the coupling of the basecoupler 850 to the access port 806. The access port 806 has a topportion (or “top ring”) 860, a bottom portion (or “bottom ring”) 862,and a middle portion (or “neck”) 864. The top ring 860 has threecoupling protrusions (also referred to as “coupling tabs”) 866 thatextend from a portion of the top ring 860 and are configured to matewith the coupling notches 856.

In one embodiment, the access port 806 is a known standard device usedin hand-assisted laparoscopic surgery. As is understood in the art, theaccess port 806 provides a structured open pathway through the cavitywall, such as the abdominal wall. at the incision site. In oneparticular example, the access port 806 is a commercially availableretractor port 806 called the DEXTRUS® Retractor, which is availablefrom Ethicon Endo-Surgery.

As best shown in FIGS. 63A and 63B, the base coupler 850 is coupled tothe access port 806 using an O-ring 868. More specifically, the O-ring868 is positioned in the lower groove 854 of the coupler 850 and the topring 860 is positioned over the lower portion of the coupler 850 and theO-ring 868 in the groove 854 such that the O-ring 868 is compressedbetween the coupler 850 and the top ring 860, thereby creating a fluidicseal between those two components.

As best shown in FIGS. 63C and 63D, as the top ring 860 is positionedover the lower portion of the coupler 850 and the O-ring 868 asdescribed above, the coupling tabs 866 of the access port 806 arecoupled with the coupling notches 856 of the base coupler 850, therebyenhancing the stability of the coupling of the coupler 850 and theaccess port 806.

FIG. 63E depicts the entire coupling of the container 802 to the accessport 806 via the coupler 850 as described above. Further, FIGS. 64A and64B depict the external pressurized insertion device 800 in use, withthe device 800 coupled to an access port 806 that is positioned in anincision in a patient's skin 870.

In use, according to one embodiment, the access port 806 and theexternal pressurized device 800 are positioned for a surgical procedurein the following manner. As an initial matter, according to oneembodiment, the robotic device 808 is positioned inside the insertiondevice 800 prior to placing the port 806 and the device 800 in theappropriate surgical position. That is, the robotic device 808 ispositioned inside the container 802, the support rods 830 coupled to thedevice 808 are secured to the top cap 804 with the set screws 840, anyconnection cables coupled to the device 808 are positioned through thelumens 824 in the top cap 804, and the flexible container 802 is coupledand fluidically sealed to the top cap 804 and the base coupler 850 viathe O-rings 828, 858. Alternatively, the robotic device 808 ispositioned inside the insertion device 800 after positioning the port806 and device 800. Regardless, as far as positioning the port 806 anddevice 800, the port 806 is positioned first in certain implementations.That is, in one embodiment, the bottom ring 862 is first insertedthrough the incision previously made in the patient's cavity wall. Oncethe ring 862 is positioned through the incision and inside the cavity,the ring 862 can help constrain the entire port 806 within the incisionby expanding to a diameter that is greater than the diameter of theincision, as best shown in FIG. 64A. In one embodiment, the container802 and the coupler 850 are coupled to the access port 806 prior topositioning the port 806 in the incision. Alternatively, the port 806 isfirst positioned in the incision, and then the coupler 850 and thecontainer are coupled to the port 806. Regardless, once the access port806 and insertion device 800 are positioned, the patient's cavity canthen be insufflated. Due to the fluidic communication between the cavityand the interior of the container 802 that is created by the access port806, the entire interior of the insertion device 800 will be under thesame pressure as the cavity.

In accordance with one implementation, once the access port 806 andinsertion device 800 are positioned correctly, the process of insertingthe robotic device 808 into the patient's insufflated cavity can takeplace in the following manner as best shown in FIGS. 65A-69B. Initially,the robotic device 808 begins with both arms parallel and vertical tothe incision, as best shown in FIGS. 65A and 65B. Then, the robot 808 islowered through the opening created by the access port 806 as shown inFIGS. 66A and 66B. In accordance with one embodiment, as best shown bycomparing FIGS. 65A and 65B with FIGS. 66A and 66B, as the robot 808 islowered, the flexible container 802 shrinks in height by allowingportions of the flexible material of the container 802 to “crumple” orbegin forming folds such that the top cap 804 moves closer to the accessport 806.

As best shown in FIGS. 67A and 67B, according to one embodiment, oncethe “elbow joints” of the arms of the robotic device 808 have clearedthe cavity wall and access port 806, the forearms are rotated at theelbow joints until the forearms are positioned at an angle of or near45° in relation to the upper arms (as best shown in FIG. 67A).Concurrently, the “upper arms” are rotated at the “shoulder joints”until the upper arms are positioned at an angle of or near 20°, as bestshown in FIG. 67B. This rotation of the forearms and upper arms can helpto ensure that the device 808 will fit within the patient's targetcavity so that any contact of the robotic device 808 with any internaltissues or organs is minimized or eliminated. Alternatively, theforearms and upper arms can be rotated to any angle that minimizes therisk of contact with tissues or organs.

As best shown in FIGS. 68A and 68B, according to one embodiment, thedevice 808 can be inserted further into the patient's cavity by furtherpositioning the arms of the device 808 while the container 802 continuesto crumple, thereby resulting in further shrinkage of the insertiondevice 800. More specifically, the upper arms can be rotated furtheruntil they are positioned at an angle of or near 45°, as best shown inFIG. 68B. This process of moving the device 808 further into the cavitywhile positioning the arms to avoid contact with organs or tissues andcausing the container 802 to crumple is continued until the shoulderjoints of the device 808 have cleared the cavity wall and access port806.

At this point, as best shown in FIGS. 69A and 69B, the forearms can berotated back to center and the upper arms can be further rotated up,leaving the arms in an appropriate starting position for a surgicalprocedure. Once in the desired starting position, the device 808 can belocked or otherwise stabilized in place using a known external clampingmechanism such as, for example, an Iron Intern®, which is commerciallyavailable from Automated Medical Products Corp.

FIG. 70 depicts another implementation of an external pressurized systemor apparatus 900. The apparatus 900 has a container 902 with a top cap904 coupled to a top portion of the container 902. In this embodiment,the container 902 has a port 906 that is coupled to the container 902 ata base portion of the container 902. The port 906 is configured to bepositionable in an incision in the skin of the patient, therebyproviding access to a cavity of the patient. As shown in FIG. 70, theapparatus 900 is configured to receive a surgical device 908 such thatthe device 908 can be inserted into the patient cavity through the port906 of the apparatus 900.

According to one embodiment, like the container 802 described above anddepicted in FIGS. 55-69B, the container 902 in this device 900 is madeof a flexible material such as, for example, polyethylene plastic,latex, nylon, or silicone rubber.

In this embodiment, the top cap 904, the container 902, and the roboticdevice 908 are substantially similar to the top cap 804 and container802 depicted and described above. All the various features andcomponents described above apply to these top cap 904, container 902,and device 908 embodiments as well.

FIGS. 71A and 71B depict the base coupling component (also referred toas the “base coupler”) 920 that is coupled to a bottom portion of thecontainer 902. The base coupler 920 has a groove 922 and three couplingprotrusions 924 that extend from the coupler 920. In accordance with oneimplementation, each of the coupling protrusions 924 has a lumen 926configured to receive a thumb screw 928. The container 902 is coupled tothe base coupler 920 using an O-ring 930. More specifically, thecontainer 902 is positioned over the upper portion of the coupler 920such that the container 902 is positioned over the groove 922 andadjacent to or against the three protrusions 924. The O-ring 930 ispositioned over the container 902 at the groove 922 such that the O-ring930 urges a portion of the container 902 into the groove 922, therebycreating a fluidic seal between the container 902 and the base coupler920.

In this embodiment, the insertion device 900 has a port attachment 940that is coupleable to the base coupler 920 and the access port 906 suchthat the port attachment 940 is positioned between the coupler 920 andthe port 906. The port attachment 940 has a removable lid 944 thatmaintains a fluidic seal when the lid 944 is in place on the portattachment 940, thereby making it possible to maintain insufflation ofthe patient's cavity even when the insertion device 900 is not yetcoupled to the access port 906.

FIGS. 72A and 72B depict the coupling of the port attachment 940 to theaccess port 906. The port attachment 940 has three coupling notches 942similar to the coupling notches 856 described and depicted above. Inaddition, the port attachment 940 has a removable lid 944 (also referredto as a “removable seal component,” “removable lid seal component,” or“removable seal component”) that provides a fluidic seal when it ispositioned in its closed position in relation to the port attachment940. In the embodiment depicted in FIGS. 72A and 72B, the removable lid944 is a slidable lid 944.

Like the access port 806 described and depicted above, this access port906 (as best shown in FIG. 72A) has a top ring 946 that has threecoupling protrusions (also referred to as “coupling tabs”) 948 thatextend from a portion of the top ring 946 and are configured to matewith the coupling notches 942 in the port attachment 940.

As best shown in FIG. 72A, the port attachment 940 has an O-ring 950that can be positioned between the port attachment 940 and the accessport 906 such that the O-ring 950 creates a fluidic seal when the twocomponents are coupled together.

In use, the port attachment 940 can be coupled to the access port 906 bypositioning the bottom portion of the port attachment 940 in the topportion of the top ring 946 with the O-ring 950 positioned between thetwo components, with the coupling notches 942 on the port attachment 940mating with the coupling protrusions 948 on the top ring 946.

The port attachment 940 also has another O-ring 952 that is configuredto be positioned in the groove 954 formed in the top of the portattachment 940. In one embodiment, the O-ring 952 can be placed in thegroove 954 to help create an airtight seal when the port attachment 940is coupled to the base coupler 920.

Further, the port attachment 940 also has three threaded lumens 956 inthe top of the attachment 940. In one embodiment, these lumens 956 areconfigured to receive the thumb screws 928 that are positioned throughthe lumens 926 in the base coupler 920, thereby allowing for couplingthe base coupler 920 to the port attachment 940 via the screws 928. Ofcourse, it is understood that other coupling mechanisms besides thumbscrews can be used. In various alternative embodiments, any knownattachment or coupling mechanism or component can be used. Somenon-limiting examples include magnets, quick clamps, quarter turnfeatures, snap-in features, and the like.

As best shown in FIGS. 73A and 73B, the slidable lid 944 can be movedbetween a closed position (as shown in FIG. 73B) and an open position(as shown in FIG. 73A). In this embodiment, the slidable lid 944 ispositioned in the port attachment 940 via a lid slot 958 in the portattachment 940. In the open position, tools or robotic devices can bepassed through the port attachment 940 and the access port 906. In theclosed position, a fluid seal is established between the lid 944 and theport attachment 940, which makes it possible to insufflate the patient'scavity prior to attaching the insertion assembly 900. It is understoodthat while this embodiment of the removable lid 944 is a slidable lid944, any other known method or device for establishing a fluidic sealcould be used. Non-limiting examples include a mechanical iris, leafshutter, or any other known method of providing a removable fluidicseal.

FIGS. 74A and 74B depict cross-sectional views of the entire lowersubassembly as described above, including the base coupler 920, the portattachment 940, and the access port 906. More specifically, FIG. 74Ashows the port attachment 940 coupled to the access port 906, with theslidable lid 944 fully inserted into the port attachment 940 in theclosed position, thereby creating a fluidic seal. FIG. 74B shows allthree components coupled together, including the base coupler 920, theport attachment 940, and the access port 906.

FIGS. 75A, 75B, and 75C depict the external pressurized insertion device900 in use, according to one embodiment. Once the access port 906 ispositioned in the incision as discussed above, the port attachment 940can be coupled to the port 906, as best shown in FIG. 75A. With theslidable lid 944 in the closed position, a fluidic seal is establishedbetween the port attachment 940 and the port 906 such that the patient'scavity can be insufflated to the desired Insufflation pressure. Theinsertion device 900 can then be coupled to the port attachment 940 asbest shown in FIG. 75B. Once the base coupler 920 is coupled to the portattachment 940 such that a fluidic seal is established between the twocomponents, the slidable lid 944 can then be moved to its open position(or fully remove) as best shown in FIG. 75C, thereby providing fluidiccommunication between the patient's cavity and the interior of theinsertion device 900, resulting in equalized pressure in the device 900and the cavity. The robotic device 908 can be inserted via any of thesame steps as described previously. If the device 908 completes thedesired surgical procedure and a different robotic device or other typeof tool needs to be used, the robotic device 908 can be removed from thecavity, the slidable lid 944 can be replaced in the closed position, andthe base coupler 920 can be removed from port attachment 940. Thisallows pressure to be maintained within the cavity, even during toolchanges.

FIG. 76 depicts an alternative embodiment having a top cap 960 that hasa pressure relief valve 962. During the process of lowering either ofthe robotic devices 808, 908 out of the insertion device embodiments800, 900 and into the cavity as described above with respect toinsertion devices 800 and 900, there is a pressure increase in thepatient's cavity due to the decreasing change in volume of the container802, 902. The pressure relief valve 962 can be configured to releasepressure if the internal insufflation pressure increases above a typicalvalue, thereby aiding the process of inserting the robotic device 808,908 such that the attendant will not need to wait for the pressure toequalize between the cavity and the insertion device 800, 900.

Another implementation of a top cap 1000 having a pressure relief valve1002 is depicted in FIGS. 77A and 77B. This cap 1000 also has a dualport seal component 1004 that can be configured to receive one or moresurgical instruments or devices such as a standard laparoscopic tool.Alternatively, it is contemplated that a top cap can have only one ofthe pressure relief valve 1002 or the dual seal component 1004.

As best shown in FIG. 77B, according to one implementation, the pressurerelief valve 1002 has an adjustment component (also referred to as anadjustment “door,” “wall,” or “button,” or “block”) 1006 that isoperably coupled to (or positioned against) one end of a tension spring1008 and has two holes 1010A, 1010B that are configured to receiveretention mechanisms such as bolts, screws, or other such standarddevices or components configured to hold the adjustment component 1006in place. The other end of the spring 1008 is coupled to a valve ball1012 that is positioned against a rim 1016 of an opening 1014 on theunderside of the top cap 1000. The spring 1008 is configured to urge theball 1012 toward the opening 1014 such that the ball 1012 (which has alarger outer diameter than the inner diameter of the rim 1016) contactsthe rim 1016 of the opening 1014 and thereby establishes a fluidic sealbetween the ball 1012 and the rim 1016. In this embodiment, theadjustment block 1006 is adjusted using the retention mechanisms to movethe block 1006 toward or away from the ball 1012, thereby increasing ordecreasing, respectively, the force applied by the spring 1008 againstthe ball 1012 (and thereby increasing or decreasing, respectively, thestrength of the seal between the ball 1012 and the rim 1016 of theopening 1014). Thus, the adjustment block 1006 can be used to adjust thestrength of the seal based on the target maximum pressure threshold suchthat when the target maximum pressure threshold is reached (such aswhile lowering either of the robotic devices 808, 908 out of theinsertion device embodiments 800, 900 as described above), the ball 1012is urged away from the rim 1016 and the seal between the rim 1016 andthe ball 1012 is broken such that the pressure is reduced by the gasescaping through the valve 1002.

In an alternative embodiment, any known pressure relief valve for use inmedical devices can be incorporated into the top cap 1000.

Continuing with FIG. 77B, the dual port seal component 1004 in thisembodiment has two seal components: an elastic circular seal 1018defining an opening 1020 and a flap seal 1022 in fluid communicationwith the circular seal 1018. The elastic circular seal 1018 isconfigured to form a strong seal around the smooth surfaces of astandard laparoscopic tool positioned through the opening 1020. In oneimplementation, the flap seal 1022 is a secondary seal that provides afluid seal when no tool is positioned through the dual port sealcomponent 1004. That is, when no tool is positioned therethrough, thetwo flaps 1024A, 1024B are urged into contact with each other by thepressure in the patient's insufflated cavity such that the two flaps1024A, 1024B form a fluidic seal.

In an alternative embodiment, any known port seal component for use inestablishing a fluidic seal with a laparoscopic tool positionedtherethrough can be used.

According to various additional implementations, the insertion devicesdisclosed or contemplated herein can have one or more sensors or othertypes of measurement mechanisms for measuring the insertion depth of thesurgical device being inserted into the patient's cavity.

As an example, FIGS. 78A, 78B, and 78C depict an automatic insertiondevice 1030 having a flexible container 1038 and an actuator and sensorpackage 1032. The actuator can be any known actuation device, including,for example, motor and gears, motor and timing belts, linear screw,pneumatics, hydraulics, or the like. The sensor could be any knownsensing device, including, for example, a potentiometer, an encoder,optical sensors, or the like. When actuated, the actuator and sensorpackage 1032 lowers the surgical device 1034 through the incision. Thatis, as shown in FIG. 78B, the top portion of the device 1030 is urgedtoward the bottom portion of the device 1030 such that the overallheight of the device 1030 is reduced and the surgical device 1034 ismoved distally out of the bottom portion of the insertion device 1030.As the insertion occurs, the sensor in the package 1032 is configured toread the distance the surgical device 1034 has been inserted into thepatient's cavity. Based on this distance, in one embodiment, the controlprogram of the surgical device 1034 can actuate the motors of thesurgical device 1034 to move the arms into desirable positions so as toavoid making contact with any organs or a cavity wall. The process canthen be reversed to remove the surgical device 1034 from the incision.In another implementation, an additional actuator 1036 could be used togrossly position the surgical device 1034 during the insertion processor during the surgery in order to access multiple quadrants of thepatient's cavity. This actuator 1034 rotates the upper portion of theinsertion device 1030 relative to the access port. This rotation ispossible because of the flexible nature of the container 1038.

FIG. 79 depicts another embodiment of an insertion device 1050 havingone or more measurement mechanisms 1054 for measuring the insertiondepth of the surgical device that is being inserted into the patient'scavity using the insertion device 1050. In this embodiment, theinsertion depth of the surgical device is determined by measuring therelative distance between the top cap 1052 and the port 1056. Further,in this embodiment, the measurement mechanism 1054 is a sensor 1054 thatis coupled to, integrated into, or otherwise associated with the top cap1052. Alternatively, the top cap 1052 can have two or more sensors 1054.According to one embodiment, the sensor 1054 uses ultrasonic or infraredenergy and transmits the energy toward the port 1056. The energy isreflected by the port 1056 back to the sensor 1054. In this embodiment,the sensor 1054 is a range finder that can utilize the energy reflectedback from the port 1056 to determine the distance between the top cap1052 and the port 1056. The distance between the top cap 1502 and theport 1056 can then be used to calculate the insertion depth of thesurgical device.

In an alternative embodiment using a continuous sensor system, theinsertion device 1050 has not only the sensor 1054 associated with thetop cap 1052, but also a sensor (not shown) associated with the port1056. In this implementation, the sensor 1054 emits energy that isreceived by the sensor associated with the port 1056, which triggers thesensor associated with the port 1056 to transmit energy back to thesensor 1054 associated with the top cap 1052. The sensor 1054 or aseparate controller can then calculate the distance between the top cap1052 and the port 1056, which can then be used to calculate theinsertion depth of the surgical device.

In a further alternative, the measurement mechanism 1054 in the top cap1052 is a camera 1054. The camera 1054 can utilize known imageprocessing techniques on known features of the surgical device todetermine the insertion depth of the device.

FIG. 80 depicts another embodiment relating to a port 1060 of aninsertion device having one or more measurement mechanisms 1062 formeasuring the insertion depth of a surgical device. In thisimplementation, as the surgical device (not shown) is urged through theport 1060 and into the patient's cavity, characteristics of the surgicaldevice can be detected using the measurement mechanism(s) 1060associated with the port 1060. And those characteristics can be used toestimate or determine the insertion depth of the surgical device. In oneembodiment, the measurement mechanism 1062 is a camera 1062 that can useimage processing to capture and recognize the portion of the surgicaldevice that is passing through the opening 1064 in the port 1060.Alternatively, the surgical device can be marked with some type ofmarkers that are easily recognized by the image processing technology.Upon recognition of the device portion or the marker, the camera 1062 ora separate processor or controller can calculate the insertion depth ofthe surgical device based on that information.

In a further implementation, the measurement mechanism 1062 is an RFIDsensor 1062 that can sense one or more RFID markers (not shown) that arecoupled to or implanted in the surgical device (not shown) passingthrough the port 1060. Alternatively, the RFID markers in thisembodiment could also contain extra information that could be used in atwo-way communication system. That is, one or more of the markersassociated with the surgical device could be configured to transmitinformation through the same RF link to the sensor and/or a controller.

FIG. 81 depicts another embodiment of an insertion device having ameasurement mechanism that measures the relative distance between thetop cap and the port to determine the insertion depth of the surgicaldevice. This embodiment relates to a top cap 1070 that has a stringmeasurement system 1072, which, in some embodiments, is a stringpotentiometer system 1072. The string measurement system 1072 is asystem in which a string is extended from the top cap 1070 to the port(not shown) at the bottom of the insertion device (not shown) and theamount of string that extends from a rotatable drum is measured. In thisembodiment, the system 1072 has a rotatable sensor 1074, a rotatabledrum 1076, a spring-loaded string dispenser 1078, and string (not shown)extending from the dispenser and around the drum 1076. According to oneembodiment, the sensor 1074 is a potentiometer 1074, and in somespecific embodiments, the sensor 1074 is a multiple-turn potentiometer1074. The rotatable sensor 1074 is coupled to the rotatable drum 1076such that the sensor 1074 rotates when the drum 1076 rotates. In oneembodiment as shown, the drum 1076 is a dual drum 1076 having ameasurement string drum half 1076A and a spring-loaded string drum half1076B. More specifically, the string that extends down to the port (notshown) of the insertion device (not shown) wraps around the measurementstring drum half 1076A, while a separate spring-loaded string (notshown) that is coupled at the other end to the spring-loaded stringdispenser 1078 wraps around the spring-loaded string drum half 1076B.

Alternatively, the system 1072 can have a single string (not shown). Forexample, in one embodiment, a string (not shown) is coupled directly tothe rotatable sensor 1074. In a further embodiment, the stringmeasurement system 1072 can be used to measure the tilt of the insertiondevice (or the canister of the insertion device). According to oneimplementation, the string measurement system 1072 uses three strings tomeasure the tilt.

In use, the sensor 1074 can detect the distance between the top cap 1070and the port (not shown) by sensing the number of turns of the drum1076, as the number of turns is directly related to the length of thestring extending down to the port (not shown) and thus directly relatedto the distance between the top cap 1070 and the port (not shown). Thisinformation can be used to calculate the insertion depth of the surgicaldevice.

In an alternative embodiment, more than one measurement mechanism can beincorporated into an insertion device. That is, a first measurementmechanism can be incorporated into the insertion device to measure theinsertion depth of the surgical device while a second measurementmechanism can be incorporated to measure the amount of “tilt” in theinsertion device. It is understood that this could be any combination ofthe measurement devices that are capable of measuring depth and/or tilt.It is further understood that any known device for measuring tilt asdescribed herein can be used within the insertion devices contemplatedherein. In this context, “tilt” is intended to mean the angle of thelongitudinal axis of the canister in relation to the plane parallel tothe radius of the incision port. Several embodiments of the canistersand insertion devices herein are configured to allow for such tilt,which can be utilized to better position the surgical device in thecavity once it has exited the interior of the canister prior to orduring a procedure.

FIGS. 82A, 82B, 82C, 82D, and 82E depict yet another implementation ofan insertion device having a measurement mechanism that measures therelative distance between the top cap and the port to determine theinsertion depth of the surgical device. This embodiment relates to a topcap 1090 that has a substantially rigid structure measurement system1092. The measurement system 1092 is a system in which a substantiallyrigid structure 1094 extends from the top cap 1090 to the port 1096 atthe bottom of the insertion device and the displacement of the structure1094 is measured to determine the distance between the top cap 1090 andthe port 1096, which can be used to calculate the insertion depth of thesurgical device.

In this embodiment, as shown in FIG. 82A, the substantially rigidstructure is a square bar 1094 that has a coupler 1098 at the top of thebar 1094. The bar 1094 extends through a seal 1100 in the top cap 1090(as best shown in FIG. 82A), through a hole 1102 in the underside of thetop cap 1090 (as best shown in FIG. 82B), and through a hole 1104 in theport 1096 (as best shown in FIG. 82E). In one embodiment, the hole 1102in the top cap 1090 is square and thus the square bar 1094 cannot rotatein relation to the top cap 1090 (and thus can't rotate in relation tothe insertion device). According to one implementation, the seal 1100 inthe top cap 1090 is an elastomeric seal 1100. Alternatively, the seal1100 is any seal that can maintain the pressure in the insertion devicewith the bar 1094 disposed therethough.

In one embodiment, the actual measurement of the displacement of thesquare bar 1094 is accomplished using a string measurement system suchas the system described above with respect to FIG. 81. The coupler 1098on the top end of the square bar 1094 is configured to be coupleable toa string (not shown) that is coupled in turn to the drum 1106 of thestring measurement system 1108. In one embodiment the string measurementsystem 1108 operates in the same fashion as the similar system above.

As best shown in FIGS. 82C, 82D, and 82E, the bottom of the square bar1094 is constrained in the port 1096 via a pegged ball 1110 having fourpegs that is positioned in a cavity 1112 defined in the underside of theport 1096, wherein the cavity 1112 is in fluid communication with thehole 1104 in the top side of the port 1096. The cavity 1112 isconfigured to match the configuration of the pegged ball 1110 as shown(with the four slots in the cavity 1112 matching with the four pegs ofthe ball 1110) such that the ball 1110 can move within the cavity 1112in a way that allows angular offset but not rotation about thelongitudinal axis of the bar 1094. According to one embodiment, thecombination of this constraint and the rotational constraint at the topcap 1090 allows the surgical device to be maneuvered into the body (thatis, the insertion device can be tilted as described elsewhere herein andthereby maneuver and position the surgical device), but will maintainthe centerline of the robot lined up with the insertion point.

In an alternative embodiment, the substantially rigid structure isanother shape other than square. In a further implementation, thestructure can have any shape that can match with a hole in the top capsuch that the structure cannot rotate in relation to the top cap.Alternatively, the substantially rigid structure can be made up of morethan one bar. For example, in one alternative embodiment, there can betwo substantially rigid structures extending from the top cap to theport. In a further alternative, there are three or more structures.

Various other implementations of measurement mechanisms can beenvisioned that fall within the scope and spirit of the embodimentsdisclosed herein. For example, while various embodiments discussed aboverelate to measurement of the relative distance between the top cap andthe port, other alternative embodiments can measure the relative angularand linear displacement between the top and bottom of the insertiondevice. In addition, while various embodiments discuss above relate tosensors configured to emit and/or sense particular types of energy (suchas infrared or ultrasonic energy), it is understood than any type ofwireless technology that would work with a sensor can be used.

It is understood that any of these measurement technologies can beincorporated into any of the insertion device embodiments disclosedherein.

FIG. 83 depicts an alternative embodiment of an incision port 1120 thatcan be used with any of the insertion devices described above. In thisimplementation, the incision port 1120 has a slidable lid 1122 similarto the lid depicted in FIGS. 72A-75C. Further, the port 1120 also has aninsufflation port 1124 that is in fluidic communication with theinterior lumen or opening of the incision port 1120. In this embodiment,the insufflation port 1124 is a flow valve port 1124 that is positionedon the port 1120 such that it is below the slidable lid 1122. In oneimplementation, the insufflation port 1124 is used to insufflate thepatient's cavity or to provide supplemental insufflation during aprocedure. In use, the lid 1122 is positioned in the closed position toestablish a fluid seal in the cavity (and in the insertion device, asdescribed elsewhere above), and then gas is added to the patient'scavity via the insufflation port 1124.

FIGS. 84A and 84B depict alternative insertion device embodiments that,unlike the cylindrical canisters described above, have canisters withdifferent shapes. More specifically, FIG. 84A is an insertion device1130 with a flexible canister 1132 that is spherical in shape. Further,FIG. 84B is an insertion device 1140 with a flexible canister 1142 thatis conical in shape. According to one embodiment, during compression,the spherical and conical canisters 1132, 1142 collapse or compress orotherwise allow the top cap to be moved toward the incision port suchthat the walls of the canisters 1132, 1142 expand or move outward. Thatis, the canisters 1132, 1142 do not bend inward and thereby interferewith the surgical device disposed within the canisters 1132, 1142 duringcollapse or compression of the canisters 1132, 1142.

FIGS. 85A, 85B, and 85C depict alternative insertion device embodimentsthat have canisters that are reinforced with rib structures. Morespecifically, FIG. 85A is an insertion device 1150 with a flexiblecanister 1152 having vertical rib structures 1154. FIG. 85B is aninsertion device 1160 with a flexible canister 1162 having horizontalrib structures 1164. Further, FIG. 85C is an insertion device 1170 witha flexible canister 1172 having spiral-shaped rib structures 1174. Inaccordance with one embodiment, the rib structures in these exemplaryembodiments create the structure of each canister while the flexiblematerial in the canisters maintain the pressure therein. Alternatively,any combination of the rib structures can also be incorporated into acanister. In one implementation, the rib structures providereinforcement for each canister such that the structures reduce theamount of undesired bending or collapsing of the canister during use.

FIGS. 86A, 86B, 86C, 86D depict an embodiment of a base coupler 1182 (ofan incision port 1180) that is releasably coupled to the canister 1184of the incision device. In this embodiment, the surgical device (notshown) can be positioned in the canister 1184 prior to the procedure andthen releasably coupled to the incision port 1180. The coupler 1182 hasat least one fixed support 1186 and at least one releasable latch 1188.According to one embodiment, there are two fixed supports 1186 (one isnot visible). The canister 1184 has a lip 1190 on the bottom of thecanister that can couple with the coupler 1182. In use, the canister1184 is positioned against the top of the coupler 1182 in a tiltedposition as shown in FIGS. 86B and 86C such that the lip 1190 ispositioned under the two fixed supports 1186. Then the entire bottom ofthe canister 1184 is placed into contact with the coupler 1182, therebycreating a seal between the lip 1190 and the coupler 1182. When the lip1190 is positioned correctly, the latch 1188 is moved into the latchedposition such that the lip 1190 is retained in its position against thecoupler 1182 via the two fixed supports 1186 and the latch 1188 as bestshown in FIG. 86D.

FIGS. 87A, 87B, and 87C depict an embodiment of an insertion devicehaving top cap 1200 that is coupled to an outer handle set 1202 suchthat the top cap 1200 and handle set 1202 can be moved relative to theflexible canister 1204. The outer handle set 1202 has an outer ring 1206that is positioned around the outer circumference of the top cap 1200such that there is a fluid seal established between the two components.In one embodiment, the fluidic seal is enhanced by a rubber seal 1210disposed between the top cap 1200 and outer ring 1206. Further, the set1202 also has two handles 1208 coupled to the ring 1206 such that a useror medical professional can easily grasp the set 1202. Morespecifically, as best shown in FIG. 87B, the top cap 1200 and outerhandle set 1202 are moved down over the walls of the flexible canister1204 such that the canister 1204 walls are disposed between the top cap1200 and the handle set 1202. Thus, unlike certain embodiments above,the top cap 1200 is not fixed to the top of the canister 1204, butrather can be moved distally toward the bottom of the canister 1204while pulling the walls of the canister 1204 through the seal of the topcap 1200 and outer handle set 1202 so as to reduce any bunching of thecanister walls 1204 during compression of the device. In use, the topcap 1200 is free to slide within the flexible canister 1204 and iscontrolled via the outer handle set 1202, which has handles 1208 thatprovide direct control of the position and orientation of the top cap1200.

FIGS. 88A, 88B, 88C, and 88D depict an alternative embodiment of aninsertion device 1220 having top cap 1222 (as best shown in FIGS. 88Aand 88B, a mobile seal 1224 (as best shown in FIG. 88C, an outer handleset 1226 (as best shown in FIGS. 88A and 88C) coupled to the mobile seal1224, and an incision port 1228 (as best shown in FIGS. 88A and 88D).This embodiment differs from the previous embodiment in that the top cap1222 in this device 1220 is not mobile and instead is coupled to theproximal end of the device 1220 as shown in FIG. 88A. Further, thisembodiment has a mobile seal 1224 that is capable of moving along thelength of the device 1220 in the same fashion as the top cap 1200described above and depicted in FIGS. 87A-87C. Further, the outer handleset 1226 is coupled to the mobile seal 1224, instead of the top cap1222.

According to one embodiment, the top cap 1222 in this device 1220 is theprimary seal of the device 1220 such that it is not essential that themobile seal 1224 maintains a fluidic seal as it is moved along thelength of the device 1220. As such, the top cap 1222 can have all thesealing features and components of any of the top cap embodimentsdescribed above, including seals and access openings for wires, suction,irrigation, and auxiliary tools. In accordance with one implementation,the mobile seal 1224 is used primarily, along with the outer handle set1226, to position the surgical device into the patient's cavity. Themobile seal 1224 and the outer handle set 1226 are coupled together,according to one embodiment, in a similar fashion and with similarcomponents as the outer handle set 1202 and the top cap 1200 describedabove. When the outer handle set 1226 is moved, the mobile seal 1224moves as well, and the handle set 1226 and seal 1224 can be movedrelative to the canister walls in the same way as the top cap 1200 andhandle set 1202 above.

According to one implementation, the external circumference of themobile seal 1224 is non-circular such that coupling the seal 1224 to theouter handle set 1226 restrains the mobile seal 1224 from any axialmovement in relation to the handle set 1226. As an example, the outercircumference of the seal 1224 can have the shape of a hexagon or anellipse. Alternatively, any mechanism or component to restrain suchaxial movement can be used.

In one embodiment, the interface of the mobile seal 1224 and outerhandle set 1226—where the canister is positioned and must passthrough—need not provide a fluidic seal. Further, in certainimplementations, the additional mechanisms or components such as ballbearings or surfaces conducive to movement can be incorporated into theinterface, thereby enhancing the ability of the canister wall to passthrough the interface easily. It is understood that these mechanisms orcomponents can be incorporated into the seal 1224 or the handle set 1226or both.

FIG. 89 depicts an alternative embodiment of an insertion device 1240having a substantially non-flexible canister portion 1242 that iscoupled to a flexible canister portion 1244, which in turn is coupled tothe incision port 1246. In this embodiment, the top cap (not shown) canbe coupled to an outer handle set similar to that described above suchthat the top cap can move along the non-flexible canister portion 1242with ease. The flexible canister portion 1244 provides a flexibleconnection or interface (which could also be described as a “ball jointlike” interface) that allows the movement of the surgical device asneeded. That is, the flexible canister portion 1244 enhances the abilityto tilt the insertion device 1240 as described above, thereby enhancingthe ability to move the surgical device during insertion and during anyprocedure being performed. In one implementation, the coupling of thetop cap and the outer handle set can be a magnetic connection so as toavoid the necessary sealing. Alternatively, different canister shapesand sizes can be envisioned. Further, the flexible canister portion canbe located elsewhere on the device. In a further alternative, more thanone flexible canister portion can be provided.

It is understood with respect to all of the various embodimentsdescribed herein that the medical devices being inserted into thepatient are any known medical or surgical devices for performingprocedures within a cavity of a patient. In certain embodiments, it isunderstood that the medical devices are robotic surgical devices havingone or two arms. In various alternatives, the robotic surgical devicesor systems can have or use three or more arms. In further alternatives,the devices (or additional devices) can be cameras or camera systems.Yet other alternatives, include the use of “helper” tools that can beinserted along with one or more medical devices or robotic devices.

Although the present invention has been described with reference topreferred embodiments, persons skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

What is claimed is:
 1. A surgical insertion device comprising: (a) abase ring defining a base ring opening, the base ring configured to beoperably coupleable to a standard sleeve device; (b) a first top ringdefining a first top ring opening, the first top ring configured to beoperably coupled to the base ring; and (c) at least one first sealdisposed between the base ring and the first top ring, the at least onefirst seal defining at least first and second seal openings, wherein thetop ring opening, the base ring opening and the first and second sealopenings are configured to receive a medical device positionedtherethrough, wherein the base ring, the first top ring, and the atleast one first seal are configured to maintain a fluidic seal at anincision when the medical device is positioned therethrough.
 2. Thesurgical insertion device of claim 1, wherein the first seal opening isa first slit and the second seal opening is a second slit.
 3. Thesurgical insertion device of claim 2, wherein the first slit is largerthan the second slit.
 4. The surgical insertion device of claim 1,wherein the at least one first seal comprises three seals.
 5. Thesurgical insertion device of claim 1, wherein the at least one firstseal comprises: (a) a first seal positioned adjacent to the base ring;(b) a second seal positioned adjacent to the first seal; and (c) a thirdseal positioned between the second seal and the first top ring.
 6. Thesurgical insertion device of claim 5, wherein the first seal openingcomprises: (a) a first seal first slit defined in the first seal; (b) asecond seal first slit defined in the second seal, wherein the secondseal first slit is substantially perpendicular to the first seal firstslit; and (c) a third seal first opening defined in the third seal,wherein the first seal first slit, the second seal first slit, and thethird seal first opening are positioned in relation to each other todefine the first seal opening.
 7. The surgical insertion device of claim5, wherein the second seal opening comprises: (a) a first seal secondslit defined in the first seal; (b) a second seal second slit defined inthe second seal, wherein the second seal second slit is substantiallyperpendicular to the first seal second slit; and (c) a third seal secondopening defined in the third seal, wherein the first seal second slit,the second seal second slit, and the third seal second opening arepositioned in relation to each other to define the second seal opening.8. The surgical insertion device of claim 1, the device furthercomprising: (a) a second top ring defining a second top ring opening,the second top ring configured to be operably coupled to the first topring; and (b) at least one second seal disposed between the first topring and the second top ring, the at least one second seal furtherdefining the at least first and second seal openings, wherein the secondtop ring opening, the first top ring opening, the base ring opening andthe first and second seal openings are configured to receive a medicaldevice positioned therethrough, wherein the base ring, the first topring, the second top ring, and the at least one first and second sealsare configured to maintain a fluidic seal at an incision when themedical device is positioned therethrough.
 9. The surgical insertiondevice of claim 8, the device further comprising a cavity definedbetween the at least one first seal and the at least one second seal,wherein the cavity is configured to minimize pressure loss from any lossof the fluidic seal.
 10. The surgical insertion device of claim 8,wherein the at least one second seal comprises three seals.
 11. Thesurgical insertion device of claim 8, wherein the at least one secondseal comprises: (a) a fourth seal positioned adjacent to the first topring; (b) a fifth seal positioned adjacent to the fourth seal; and (c) asixth seal positioned between the fifth seal and the second top ring.12. The surgical insertion device of claim 11, wherein the first sealopening further comprises: (a) a fourth seal first slit defined in thefourth seal; (b) a fifth seal first slit defined in the fifth seal,wherein the fifth seal first slit is substantially perpendicular to thefourth seal first slit; and (c) a sixth seal first opening defined inthe sixth seal, wherein the fourth seal first slit, the fifth seal firstslit, and the sixth seal first opening are positioned in relation toeach other to further define the first seal opening.
 13. The surgicalinsertion device of claim 11, wherein the second seal opening furthercomprises: (a) a fourth seal second slit defined in the fourth seal; (b)a fifth seal second slit defined in the fifth seal, wherein the fifthseal second slit is substantially perpendicular to the fourth sealsecond slit; and (c) a sixth seal second opening defined in the sixthseal, wherein the fourth seal second slit, the fifth seal second slit,and the sixth seal second opening are positioned in relation to eachother to further define the second seal opening.
 14. A surgicalinsertion device comprising: (a) a base ring defining a base ringopening, the base ring configured to be operably coupleable to astandard sleeve device; (b) a first top ring defining a first top ringopening, the first top ring configured to be operably coupled to thebase ring; (c) at least one first seal disposed between the base ringand the first top ring, the at least one first seal defining at leastfirst and second seal openings, wherein the at least one first sealcomprises: (i) a first seal positioned adjacent to the base ring; (ii) asecond seal positioned adjacent to the first seal; and (iii) a thirdseal positioned between the second seal and the first top ring; (d) asecond top ring defining a second top ring opening, the second top ringconfigured to be operably coupled to the first top ring; and (e) atleast one second seal disposed between the first top ring and the secondtop ring, the at least one second seal further defining the at leastfirst and second seal openings, wherein the at least one second sealcomprises: (i) a fourth seal positioned adjacent to the first top ring;(ii) a fifth seal positioned adjacent to the fourth seal; and (iii) asixth seal positioned between the fifth seal and the second top ring,wherein the second top ring opening, the first top ring opening, thebase ring opening and the first and second seal openings are configuredto receive a medical device positioned therethrough, and wherein thebase ring, the first top ring, the second top ring, and the at least onefirst and second seals are configured to maintain a fluidic seal at anincision when the medical device is positioned therethrough.
 15. Thesurgical insertion device of claim 14, wherein the first seal openingcomprises: (a) a first seal first slit defined in the first seal; (b) asecond seal first slit defined in the second seal, wherein the secondseal first slit is substantially perpendicular to the first seal firstslit; (c) a third seal first opening defined in the third seal; (d) afourth seal first slit defined in the fourth seal; (e) a fifth sealfirst slit defined in the fifth seal, wherein the fifth seal first slitis substantially perpendicular to the fourth seal first slit; and (f) asixth seal first opening defined in the sixth seal, wherein the firstseal first slit, the second seal first slit, the third seal firstopening, the fourth seal first slit, the fifth seal first slit, and thesixth seal first opening are positioned in relation to each other todefine the first seal opening.
 16. The surgical insertion device ofclaim 14, wherein the second seal opening comprises: (a) a first sealsecond slit defined in the first seal; (b) a second seal second slitdefined in the second seal, wherein the second seal second slit issubstantially perpendicular to the first seal second slit; (c) a thirdseal second opening defined in the third seal; (d) a fourth seal secondslit defined in the fourth seal; (e) a fifth seal second slit defined inthe fifth seal, wherein the fifth seal second slit is substantiallyperpendicular to the fourth seal second slit; and (f) a sixth sealsecond opening defined in the sixth seal, wherein the first seal secondslit, the second seal second slit, the third seal second opening, thefourth seal second slit, the fifth seal second slit, and the sixth sealsecond opening are positioned in relation to each other to define thesecond seal opening.
 17. A method of providing medical device access toa cavity of a patient while maintaining insufflation of the cavity, themethod comprising: positioning a standard sleeve device in an incisionin the patient; coupling a surgical insertion device to the standardsleeve device, the surgical insertion device comprising: (a) a base ringdefining a base ring opening; (b) a first top ring defining a first topring opening, the first top ring configured to be operably coupled tothe base ring; and (c) at least one first seal disposed between the basering and the first top ring, the at least one first seal defining atleast first and second seal openings; and positioning at least a portionof a medical device into the cavity of the patient through the top ringopening, the first and second seal openings, and the base ring openingwhile maintaining a fluidic seal.
 18. The method of claim 17, whereinthe coupling the surgical insertion device to the standard sleeve devicecomprises coupling the base ring to the standard sleeve device.
 19. Themethod of claim 17, wherein the base ring comprises a circular notchdefined in the base ring, wherein the coupling the surgical insertiondevice to the standard sleeve device comprises positioning an upper ringof the standard sleeve device into the circular notch.
 20. The method ofclaim 17, wherein the maintaining the fluidic seal is accomplished viathe base ring, the first top ring, and the at least one first seal.